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enExtracorporeal Shock Wave Therapy as an Adjunct Wound Treatment: A Systematic Review of the Literaturehttp://www.o-wm.com/article/extracorporeal-shock-wave-therapy-adjunct-wound-treatment-systematic-review-literature
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/2638">Volume 60 - Issue 7 - July 2014 ISSN 1943-2720</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-index field-type-text field-label-inline clearfix"><div class="field-label">Index:&nbsp;</div><div class="field-items"><div class="field-item even">Ostomy Wound Manage. 2014;60(7):26–39.</div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Robert Dymarek, PhD, PT; Tomasz Halski, PhD, PT; Kuba Ptaszkowski, PhD, PT; Lucyna Slupska, PhD, PT; Prof. Joanna Rosinczuk, PhD, MSc; and Prof. Jakub Taradaj, PhD, PT</div></div></div><div class="field field-name-taxonomy-vocabulary-3 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Topics:&nbsp;</div><div class="field-items"><div class="field-item even">extracorporeal shock wave therapy</div><div class="field-item odd">soft tissue wounds</div><div class="field-item even">wound healing</div><div class="field-item odd">Physical Therapy</div><div class="field-item even">systematic review</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><h3>Abstract</h3>
<p> Standard care procedures for complex wounds are sometimes supported and reinforced by physical treatment modalities such as extracorporeal shock wave therapy (ESWT). To evaluate available evidence of ESWT effectiveness in humans, a systematic review of the literature was conducted using MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro databases. </p>
<!--break--><p> Of the 393 articles found, 13 met the publication date (year 2000–2013), study type (clinical study), language (English only), and abstract availability (yes) criteria. The 13 studies (n = 919 patients with wounds of varying etiologies) included seven randomized controlled trials that were evaluated using Cochrane Collaboration Group standards. Only studies with randomization, well prepared inclusion/exclusion criteria protocol, written in English, and full version available were analyzed. An additional six publications reporting results of other clinical studies including a total of 523 patients were identified and summarized. ESWT was most commonly applied once or twice a week using used low or medium energy, focused or defocused generator heads (energy range 0.03 to 0.25 mJ/mm<sup>2</sup>; usually 0.1 mJ/mm<sup>2</sup>), and electrohydraulic or electromagnetic sources. Few safety concerns were reported, and in the controlled clinical studies statistically significant differences in rates of wound closure were reported compared to a variety of standard topical treatment modalities, sham ESWT treatment, and hyperbaric oxygen therapy. Based on this analysis, ESWT can be characterized as noninvasive, mostly painless, and safe. Controlled, randomized, multicenter, blind <a href="http://sched.co/1n7b1dD" target="_blank">clinical trials</a> still are required to evaluate the efficacy and cost-effectiveness of ESWT compared to sham control, other adjunctive treatments, and commonly used moisture-retentive dressings. In the future, ESWT may play an important role in wound care once evidence-based practice guidelines are developed.</p>
<p><strong>Potential Conflicts of Interest:</strong> This systematic review was prepared as a theoretical part of the project funded by the Polish National Science Centre allocated on the basis of decision no. DEC–2011/03/N/NZ7/00327.</p>
<h3>Introduction</h3>
<p> Management of soft tissue wounds remains a medical problem and a challenge, not only for internal medicine, dermatology, trauma, surgery, and angiology specialists, but also for physiotherapists in their daily rehabilitation practice.<sup>1</sup></p>
<p> Chronic wounds are defined as wounds that have not proceeded toward healing in an orderly and timely (more than 3 months) fashion through tissue repair to reconstitute anatomic and functional integrity.<sup>2</sup> The most common types of chronic wounds include venous leg ulcers (VLU), diabetic foot ulcers (DFU), pressure ulcers (PU), and arterial insufficiency ulcers (AIU). Acute wounds involve sudden skin disturbance and are expected to progress through the phases of normal healing, resulting in wound closure. Acute wounds include burn wounds (BW), postsurgical wounds (SW), and post-traumatic wounds (TW).<sup>1,3,4</sup></p>
<p><a href="/files/owm/owm_july2014_taradaj_kp.jpg" rel="lightbox" title="Key Points"><img src="/files/owm/small_owm_july2014_taradaj_kp.jpg" style="float:right" /></a> The primary aim in the treatment of these two pathologically distinct types of wounds is to promote tissue granulation and reepithelialization to achieve wound closure. Wound care modalities for chronic wounds include offloading (when the leg is involved), cleansing with sterile normal saline solution, surgical wound debridement, topical treatment (eg, antiseptic silver-containing dressing, silver sulfadiazine cream), antibiotic treatment, split-thickness skin grafting, and compression therapy — gold standards for the treatment of soft tissues that can be successfully supported and promoted using a variety of physical methods.<sup>5-8</sup></p>
<p> <strong>Biophysical basics and clinical efficiency of extracorporeal shock wave therapy.</strong> Extracorporeal shock wave therapy (ESWT) is an adjunct medical procedure aimed to improve the skin condition of patients with chronic and acute soft tissue wounds. ESWT is defined as a sequence of biphasic, high-energy acoustic pulses that generate transient pressure disturbance and propagate rapidly in three-dimensional space; this therapy is associated with a sudden rise of pressure applied directly into tissues without any damaging effect.<sup>9-11</sup></p>
<p><a href="/files/owm/owm_july2014_taradaj_f1-2.jpg" rel="lightbox" title="Figures 1-2"><img src="/files/owm/small_owm_july2014_taradaj_f1-2.jpg" style="float:right" /></a> ESWT utilizes two basic types of generators: radial and focused. They differ in terms of shock wave propagation and the physical characteristics of the energy. Radial ESWT is produced by pneumatic devices located inside the generator that create linear pressure with low energy values. The energy is produced by the pressure wave, while compressed air accelerates the cartridge strikes at the top of the applicator.<sup>12</sup> The energy generated by the pressure wave is absorbed into the skin approximately 3 cm deep and spreads a wider beam to a larger target area (see Figure 1). Focused ESWT is generated by electromagnetic, electrohydraulic, and piezoelectric sources. Pressure pulses rise rapidly in range of 10–100 MPa and concentrate the acoustic energy beam with a penetration depth of approximately 12 cm (see Figure 2).<sup>9,12,1</sup><sup>3</sup></p>
<p><a href="/files/owm/owm_july2014_taradaj_t1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/small_owm_july2014_taradaj_t1.jpg" style="float:right" /></a> Some authors describe a third type of defocused ESWT: an acoustic planar wave generated by electromagnetic and electrohydraulic devices. It is characterized by lower energy values delivered into the soft tissues and a superficial and quite large (3–5 cm2) impact zone.<sup>14,15</sup> ESWT types have been differentiated on the basis of the level of energy applied at the focal point per one pulse during treatment session — ie, energy flux density (EFD), which is determined as low energy when &lt;0.12 mJ/mm<sup>2</sup> and high energy when &gt;0.12 mJ/mm<sup>2</sup>.<sup>13</sup> Table 1 summarizes the basic characteristics of focused and radial ESWT.</p>
<p> Because of ESWT’s direct microtraumatic effects, the possibility exists for bleeding, petechiae, hematoma and/or seroma formation, and pain. A randomized, placebo-controlled, single-blind, multicenter study<sup>16</sup> conducted among 272 patients with lateral epicondylitis to analyze potential side-effects after application of shock waves found transitory reddening of the skin (21.1%), pain (4.8%), and small hematomas (3.0%) most commonly occurred. Migraine was registered in four and syncope in three instances after ESWT. The possibility of migraine being triggered by ESWT and the risk of syncope should be taken into account in the future.</p>
<p> Application of ESWT in general usage, including wound treatment, can be performed with local anesthesia (LA). However, two prospective, randomized, observer-blinded pilot trials<sup>17,18</sup> found ESWT is less effective when patients received LA. Regardless of these initial findings, the use of LA is justified, especially among patients who are unable to tolerate the procedure because of pain during the ESWT session.<sup>19</sup> Klonschinski el al’s<sup>20</sup> randomized, clinical, nonblinded study that included 20 healthy participants (10 male, 10 female; mean age 27 years, range 17–36 years) investigated whether the biological effects of ESWT differ between application with and without LA. Focused ESWT (2,000 pulses) was performed in three single sessions with different EFD levels: 0.06 mJ/mm<sup>2</sup>, 0.09 mJ/mm<sup>2</sup>, or 0.18 mJ/mm<sup>2</sup>. The results indicated that increasing EFD led to increasing pain (<em>P</em> &lt;0.001). LA reduced ESWT-related pain (<em>P</em> &lt;0.02) and prevented an ESWT-related drop in the pressure pain threshold (<em>P</em> &lt;0.001).</p>
<p> Presently, ESWT is deemed an effective and safe method of treating a wide range of pathological, in particular musculoskeletal, conditions.<sup>13,15,19</sup> The list of indications for ESWT treatment is continuously evolving and adapting to different clinical ﬁelds, including chronic and acute soft tissue wounds.</p>
<p> <strong>Potential of ESWT mechanisms in animal wound healing.</strong> The potential of the therapeutic mechanisms and clinical efficacy and safety of ESWT in musculoskeletal disorders has been well investigated. Clinical investigations aimed at achieving a positive effect in accelerating wound healing are in the initial stages, but results are encouraging.</p>
<p> Animal model experiments<sup>14</sup> illustrate ESWT for soft tissue wound healing can promote positive molecular and immunochemical reactions focused on improving blood flow microcirculation, activating anti-inflammatory response, and enhancing the tissue regeneration process. In a randomized controlled study, Goertz et al<sup>21</sup> analyzed the biological mechanisms of ESWT in blood flow enhancement in mice with full-thickness burns (n = 51). The mice were randomized into five groups: burns but no ESWT (control group); low-energy ESWT after burn injury (0.04 mJ/mm<sup>2</sup>); very low-energy shock waves after burn injury (0.015 mJ/mm<sup>2</sup>); mice without burns exposed to low-energy ESWT; and mice without burns and with no ESWT application. ESWT was performed on days 1, 3, and 7 (500 pulses, 1 Hz). Groups receiving ESWT showed accelerated <a href="http://sched.co/1n7bpsB" target="_blank">angiogenesis</a> and an increased number of rolling and sticking leukocytes in the wound area (<em>P</em> = 0.005). The authors concluded shock waves have a positive effect on several parameters of wound healing after burns, especially with regard to angiogenesis and leukocyte behavior. Moreover, shock waves increased the number of rolling and sticking leukocytes as a part of an improved metabolism in the healing process. However, obtained results should be supported by clinical studies.</p>
<p> Results of a controlled experimental trial by Hayashi et al<sup>22</sup> determined that single low-energy ESWT (focused, 0.25 mJ/mm<sup>2</sup>, 100 pulses, 4 Hz) in diabetic mice (n = 32) with skin wounds accelerated healing through the expression of endothelial nitric oxide synthase (eNOS) and generation of new vessels with the neovascularization process as an effect of vascular endothelial growth factor (VEGF) activation (<em>P</em> &lt;0.05). The authors concluded these results raised the possibility that eNOS may be involved in the beneficial effects of ESWT. In a controlled study, Kuo et al<sup>23</sup> investigated the effectiveness of ESWT in healing partial-thickness wounds in the presence of diabetes mellitus among male rats (n = 50) divided into five groups: nondiabetic control, diabetic control without ESWT, rats with one ESWT session on day 3 post-wounding, rats with two ESWT sessions on days 3 and 7, and rats with three ESWT sessions on days 3, 7, and 10. ESWT was performed using 800 pulses at 0.09 mJ/mm<sup>2</sup>. The authors confirmed significant VEGF and eNOS expression and a determined promotion of proliferating cell nuclear antigen (PCNA) associated with increased revascularization and tissue regeneration in the ESWT-treated rats, especially in the diabetic control without ESWT and one ESWT session on day 3 post-wounding groups, as compared with the control (<em>P</em> &lt;0.01).</p>
<p> Moreover, several experimental model trials (total sample: 98 rats) suggest low-energy ESWT may promote cell proliferation, increase collagen deposition, enhance granulation tissue formation, and improve blood supply through neovascularization to the post-ischemic tissue zone of skin flaps.<sup>24-27</sup></p>
<p> Another mechanism that may promote wound healing is anti-inflammatory action by a quick increase of the neuronal nitric oxide synthase (nNOS) activity and basal nitric oxide (NO) production. An experimental trial conducted by Ciampa et al<sup>28</sup> examined the effect of ESWT (focused, 500 to 1,500 pulses at 0.03 mJ/mm<sup>2</sup> and 0.11 mJ/mm<sup>2</sup>) on the modulation of nNOS catalytic activity and NO production in rat glioma C6 cells taken as a cellular model. The authors reported ESWT rapidly increased NO production by enhancing catalytic activity of nNOS, with the maximum effect achieved by use of 500 pulses at 0.03 mJ/mm<sup>2</sup> (<em>P</em> &lt;0.005).</p>
<p> It has been speculated that ESWT increased the levels of inflammatory cells — ie, pro-inflammatory cytokines and proteases. In their randomized, placebo-controlled trial, Davis et al<sup>29</sup> investigated the role of ESWT on the early proinflammatory response using a severe, full-thickness, highly inflammatory cutaneous burn wound in a murine model (n = 40). A single unfocused ESWT session was performed using 200 pulses at 0.01 mJ/mm<sup>2</sup> and 5 Hz. In this case, ESWT treatment significantly reduced the number of both infiltrating neutrophils and macrophages after injury. Furthermore, expression of proinflammatory cytokines, chemokines. and matrix metalloproteinases was globally suppressed (<em>P</em> &lt;0.05).</p>
<p> In their controlled trial, Kuo et al<sup>30</sup> used a random pattern, extended dorsal skin flap rodent model that included male rats (n = 36) divided into three groups: control group without treatment (A), rats with one ESWT session immediately after surgery (B), and rats with two ESWT sessions immediately and the day after surgery (C). ESWT was performed using 500 pulses at 0.15 mJ/mm<sup>2</sup>. Results indicated the necrotic area in the flaps in group B was significantly smaller compared with group A (<em>P</em> &lt;0.01). The authors concluded the action mechanisms of ESWT involved modulation of oxygen radicals, attenuation of leukocyte infiltration, reduction of tissue apoptosis, and recruitment of skin fibroblasts, which results in increased flap tissue survival.</p>
<p> Some data suggest an ESWT source may be used to suppress the transforming growth factor-ß1 (TGF-ß1) and increase the production of tissue granulation. In their controlled experiment among 14 healthy horses with surgically created wounds, Link et al<sup>31</sup> found ESWT treatment was associated with reduced TGF-ß1 expression during the entire study period compared to control wounds. Moreover, insulin-like growth factor-1 (IGF-1) expression was significantly increased for ESWT-treated and untreated wounds at 28 days following wound creation, compared with findings on days 7, 14, 21, and 35 (<em>P</em> &lt;0.05).</p>
<p> Inspired by the lack of relevant literature regarding a clear and well-prepared algorithm, especially on wound therapy using shock waves, a systematic review of the literature was conducted to evaluate evidence of ESWT effectiveness in humans.</p>
<h3>Methods</h3>
<p> Computer research of the following databases was performed: MEDLINE, PubMed, Scopus, EBSCOhost, and PEDro. The main keywords used for selection purposes were: <em>wound healing, venous leg ulcer, diabetic foot ulcer, pressure ulcer, arterial insufficiency ulcer, burn wound, post-traumatic wound, postsurgical wound, chronic wound, extracorporeal shock wave therapy, shock wave treatment, focused shock wave</em> (fESWT), <em>radial shock wave</em> (rESWT), and <em>defocused shock wave</em> (dESWT). Only articles published between 2000 and 2013 that involved clinical trials on human subjects, written in English, and with full-version available were included. Articles published before 2000, based on animal experiments, written in languages other than English, and versions with only abstracts were excluded. After completing the first stage of selection based on the main keywords, the abstracts of identified articles were assessed according to the eligibility criteria.</p>
<p> For the purpose of evaluating study methodological quality and validity, all included publications were divided into two groups: the first consisted of well-designed randomized trials and the second of other clinical trials.</p>
<p> All articles were assessed with regard to study methodology (types of wounds, patient characteristics, type of treatment, parameters of ESWT), the level of evidence (methods of randomization, patient allocation, blind intervention, follow-up analysis), and the results of treatment with ESWT (initial wound size, duration of wound, results of ESWT sessions, side effects after ESWT).</p>
<p> The findings were coordinated by an European Pressure Advisory Panel (EPUAP) trustee. The research team was composed of physical therapists, a nurse, a dermatologist, and a vascular surgeon experienced in wound healing treatment. The risk of bias was independently assessed with accordance to the guidelines for systematic reviews presented by Cochrane Collaboration Group. <a href="/files/owm/owm_july2014_taradaj_f3-4.jpg" rel="lightbox" title="Figures 3-4"><img src="/files/owm/small_owm_july2014_taradaj_f3-4.jpg" style="float:right" /></a></p>
<h3>Results</h3>
<p> A total of 393 articles were found. Articles published before 2000 (n = 127), based on animal experiments (n = 90), written in languages other than English (n = 73), and abstract not available (n = 90) were excluded. No systematic reviews and meta-analyses were found. Thirteen clinical trials<sup>32-44</sup> were accepted for analysis and involved a total population of 919 patients. These studies included seven randomized controlled trials (RCTs),<sup>32-38</sup> one clinical controlled trial (CCT),<sup>39</sup> three prospective clinical trials (PCTs),<sup>40-42</sup> and two clinical case reports (CCRs)<sup>43,44</sup> (see Figure 3).</p>
<p> ESWT efficacy was evaluated in patients with chronic VLU,<sup>39,40,42-44</sup> DFU,<sup>33,34,37,39</sup> PU,<sup>36,40,42</sup> AIU,<sup>40,44</sup> and acute BW,<sup>38,40-42</sup> TW,<sup>39,40,42</sup> and SW in patients with coronary artery bypass grafting (CABG)<sup>32</sup> or split-thickness skin grafting (STSG).<sup>35</sup> The authors of the vast majority of analyzed studies designed them with control groups that received standard wound care (SWC) alone at a study facility,<sup>32,34,35,38,39</sup> consisting of nonocclusive surgical dressings and antibiotic treatment,<sup>32</sup> application of topical nonadherent silicone mesh and antiseptic gel,<sup>35</sup> and wound debridement and antiseptic silver dressing.<sup>34,38,39</sup> The other control groups received SWC including offloading the affected leg, wound cleansing with sterile normal saline solution, and application of silver sulfadiazine cream combined with hyperbaric oxygen therapy (HBOT)<sup>33,37</sup> or received inactive sham ESWT.<sup>36</sup> In all the studies, participants received ESWT plus SWC procedures supported by the administration of additional antibiotics at the discretion of the treating physician. In all studies, the pre-ESWT wound dressing regimen remained unchanged and was continued after each treatment session.<sup>32-44</sup><a href="/files/owm/owm_july2014_taradaj_t2.jpg" rel="lightbox" title="Table 2"><img src="/files/owm/small_owm_july2014_taradaj_t2.jpg" style="float:right" /></a> The Cochrane-based methodological quality<sup>45</sup> of the reviewed, well-designed RCTs ranged between 8 and 15 points (11.1 ± 3.13; median 10.0) out of a total of 16 points (the more points, the higher quality of the study. See Table 2). The studies received best scores in having similar groups at baseline, regarding the most prognostic indicators (C),<sup>32-38</sup> describing dropout rate and its acceptability (I),<sup>32-38</sup> having comparable timing of outcome assessment in all groups (J),<sup>32-38</sup> and including only one type of wound (M).<sup>32-38</sup> In almost all studies, the outcome assessor was blinded to the intervention (F),<sup>32,33,35-38</sup> and the duration of the study for at least 4 (O)<sup>33-38</sup> or 10 (N)<sup>33-36,38</sup> weeks was presented in seven and six reviewed studies, respectively. In six studies, the described treatment methods in the experimental and control groups were basically correspondent, with no co-interventions (G).<sup>33-38</sup></p>
<p> On the other hand, the worst scores included lack of blinding of a patient to the intervention (D)<sup>32-34,37</sup> and care provider (E),<sup>32-38</sup> failure to include an intention-to-treat analysis (K),<sup>32-34,37</sup> and failure to achieve complete closure of all wounds (P).<sup>32-34,36,37</sup> Only three double-blind studies featured designs where patients (D)<sup>35,36,38</sup> and outcome assessors (F)<sup>35,36,38</sup> were blinded to the intervention.</p>
<p> In three of the studies, methodological issues concerning adequate methods of randomization (A)<sup>33,34</sup> and concealing the treatment allocation (B)<sup>32-34</sup> remained unclear. In two studied experiments, compliance to the intervention was acceptable in all groups (H).<sup>33,34</sup> In most studies, ESWT was applied to at least 10 participants (L).<sup>32-35,37,38</sup> Wounds completely closed in only two of the studies (P).<sup>35,38</sup></p>
<p> Overall, four of the studies in this review were awarded high scores of at least 10 points<sup>35,38</sup> from the listed methodological quality criteria; three were of low quality, scoring 8<sup>32,34</sup> or 9 points.<sup>33</sup> Three of the high-scoring studies addressed SW, DFU, and BW, reporting complete epithelialization that led to wound closure after 9.6<sup>38</sup> or 13.9 days<sup>35</sup> of ESWT treatment. In the lowest scoring of the four, which discussed PU, the authors observed a healed area in 67.45% of the study participants after a total of 6 to 8 weeks of ESWT treatment.<sup>36</sup></p>
<p> Two of the low-quality studies featured DFU; their results showed a range of 31.0% to 53.5% completely healed wounds in the ESWT groups, compared with 22.0% to 33.3% in the controls.<sup>33,34</sup> In the low-quality study that addressed SW, the authors noted an improvement of wound healing, indicated by better postoperative wound infection, including additional treatment, presence of serous discharge, erythema, purulent exudates, separation of deep tissue, isolation of bacteria, and duration of inpatient stay (ASEPSIS) scores and decreased necessity for antibiotic treatment.<sup>32</sup></p>
<p><a href="/files/owm/owm_july2014_taradaj_t4.jpg" rel="lightbox" title="Table 4"><img src="/files/owm/small_owm_july2014_taradaj_t4.jpg" style="float:right" /></a> <a href="/files/owm/owm_july2014_taradaj_t3.jpg" rel="lightbox" title="Table 3"><img src="/files/owm/small_owm_july2014_taradaj_t3.jpg" style="float:right" /></a> <strong>Evidence from well-designed RCTs (see Table 3 and Table 4).</strong> In Dumfarth et al’s<sup>32</sup> controlled study, 100 patients were randomly assigned to prophylactic low-energy ESWT (n = 50) or control without ESWT (n = 50). All consecutive participants underwent CABG surgery and were receiving intraoperative antibiotic treatment. A single session of ESWT was performed at the site of vein harvesting immediately after the wound was closed under sterile conditions using absorbable subcutaneous sutures and staples. ESWT was generated by an electromagnetic wave focusing source using an EFD at 0.1 mJ/mm<sup>2</sup> at a frequency of 5 pulses per second (5 Hz), and 25 pulses per cm of wound length. Total ESWT treatment time was 10 minutes. Ultrasonic transmission gel (USG) was used as contact medium. The primary endpoint was to assess wound healing quantified by score points including ASEPSIS. Secondary endpoints were the need for surgical revisions of the vein graft harvesting site and need for antibiotic treatment of wound healing disturbances. Researchers noticed lower ASEPSIS scores, indicative of improved wound healing, in patients receiving ESWT (4.4 ± 5.3) compared with control group patients (11.6 ± 8.3) (<em>P</em> = 0.0001). Moreover, ESWT was characterized by a significantly lower incidence of wound healing disorders, with the necessity for antibiotic intervention of 4%, compared with control of 22% (<em>P</em> = 0.015). No significant differences in episodes of surgical revision of the leg wound and no adverse events were observed.</p>
<p> In a randomized, single-blind, controlled study, Wang et al<sup>33</sup> assessed ESWT efficacy in treating chronic DFU. Seventy-two (72) patients were randomized to receive either ESWT (n = 34 out of 36 with DFU) or HBOT (control; n = 36 DFU). ESWT was performed without anesthesia, and the DFU was covered with sterile cellulose barrier. USG sterile gel was applied to the area of skin in contact with the ESWT generator head. Focused ESWT was provided every 2 weeks for a total of three treatments over 6 weeks using an electrohydraulic shock wave device with an EFD at 0.11 mJ/mm<sup>2</sup> and 300 + 100 pulses/cm<sup>2</sup> of wound; the frequency was not documented. HBOT was performed once a day, five times a week, for a total of 20 treatments. All patients received the same local wound care regimen that included wound cleansing and silver sulfadiazine cream. At the end of the study (3 months), ESWT-treated wounds healed completely in 31% of cases, improved in 58%, and were unchanged in 11%, compared to 22% completely healed, 50% improved, and 28% unchanged after HBOT (<em>P</em> = 0.001). Significant improvement was noted in the local blood flow perfusion (<em>P</em> = 0.04) of persons in the ESWT group, compared with the results of the HBOT group (<em>P</em> = 0.30). Bacteriostatic effect was documented in both ESWT and HBOT patients. Histomorphological examination of the biopsy specimens showed lower cell concentration and less cell proliferation and activity after HBOT (<em>P</em> = 0.42) as compared to ESWT (<em>P</em> = 0.002). Immunohistochemical analysis showed a significant increase in eNOS (<em>P</em> &lt;0.001), VEGF (<em>P</em> &lt;0.001), and PCNA (<em>P</em> = 0.005), as well as a lower expression of transference-mediated digoxigenin-deoxy-uridine-triphosphate nick end-labeling (TUNEL) (<em>P</em> &lt;0.001) in the ESWT than in the HBOT group (<em>P</em> &gt;0.05). Authors did not observe any adverse events and complications following ESWT.</p>
<p> In a prospective, randomized, controlled trial, Moretti et al<sup>34</sup> studied 30 persons with neuropathic DFU; 15 were treated with SWC and ESWT and 15 received SWC alone. No local anesthetic was used during ESWT treatment, which was generated by a focused electromagnetic ESWT applicator using an EFD at 0.03 mJ/mm<sup>2</sup> and 100 pulses/cm<sup>2</sup> of wound; the frequency was not described. ESWT protocol consisted of one session every 72 hours, resulting in a total of three treatments in 9 days. Each ESWT session lasted &lt;1 to 2 minutes. Researchers noted complete DFU closure in 53.33% of the ESWT-treated patients, compared with 33.33% patients in the control group; the healing time was also shorter for ESWT patients (60.8 ± 4.7 days) compared to controls (82.2 ± 4.7 days) (<em>P</em> &lt;0.001). Significant improvement of the re-epithelialization index was observed among the ESWT group (2.97 ± 0.34 mm2/die) and control patients (1.30 ± 0.26 mm<sup>2</sup>/die) (<em>P</em> &lt;0.001). Some adverse effects (eg, symptoms of local infection) were noted, and oral antibiotics were prescribed. Two patients, one in each group, developed complications that resolved within 5 to 7 days, and the patients were allowed to remain in the study.</p>
<p> In a randomized, prospective, double-blind trial, Ottomann et al<sup>35</sup> enrolled 28 patients with acute traumatic wounds and burns at a minimum size of 200 cm<sup>2</sup> that required STSG. All participants were blinded and randomized to either a group receiving (n = 13) or not receiving ESWT (n = 15). In both groups, graft donor sites were treated with SWC. A single session of ESWT was performed immediately after STSG harvest and delivered intraoperatively on the donor site of the anesthetized patient. ESWT was generated by a defocused electrohydraulic source using an EFD at 0.1 mJ/mm<sup>2</sup> and 100 pulses/cm<sup>2</sup> of donor site surface area; the frequency was not documented. The total average ESWT time was 13 minutes. Sterile USG-conducting gel applied onto a sterile plastic drape was used as a contact medium. The primary outcome was time to complete donor site healing, defined as &gt;95% reepithelialization. Average hospitalization time was 15 days, with a follow-up period of 12 weeks after hospital discharge. All donor sites healed, but significantly faster reepithelialization was documented in the ESWT (13.9 ± 2.0 days) than in the control group (16.7 ± 2.0 days) (<em>P</em> = 0.0001). No post-ESWT related complications were noted in the control group.</p>
<p> Larking et al<sup>36</sup> conducted a double-blind, randomized, cross-over study, with a population of nine severely disabled patients with chronic PU. All study participants were randomly allocated by a blinded assessor to active or placebo ESWT. Three weeks of observation with weekly measurements was conducted before the start of the interventions. After 6 weeks, including a 2-week washout phase, the ESWT group and sham ESWT group were swapped. In both groups, SWC was continued. ESWT treatment was generated by a defocused electrohydraulic system using an EFD at 0.1 mJ/mm<sup>2</sup> and 200 + 100 pulses/cm<sup>2</sup> of PU area at a frequency of 5 Hz. ESWT protocol for both phases of active and sham ESWT consisted of one session every week, resulting in a total of four treatments during 4 weeks. Sterile USG gel was applied to the clean wound and the surface of the ESWT applicator head, and a sterile drape was placed on the wound site. Results indicated improved healing in all patients with chronic PU without any significant differences between groups, regardless of commencing the study with active (67.45% average healed area) or sham ESWT (64.25% average healed area). A statistically significant difference was observed between the period of PU improvement following the start of ESWT after 8 weeks in the ESWT-first study group and after 6 weeks in the sham-first study group (<em>P</em> &lt;0.05). Authors described an enlargement of three PU during ESWT phase, two of which were previously classified for surgical debridement that was not necessary after ESWT. Authors hypothesized the ESWT seemed to heal wounds more rapidly by causing the tissue with poor viability to break down.</p>
<p> In a prospective, open-label, randomized, single-blinded study, Wang et al<sup>37</sup> randomized 77 patients with chronic DFUs into an ESWT (n = 39 out of 44 DFU) and an HBO treatment group (n = 38 out of 40 DFU). ESWT was performed without anesthesia, and the DFUs were covered with a sterile cellulose barrier. USG sterile gel was applied to the area of skin in contact with the ESWT generator head. ESWT was generated by a defocused electromagnetic applicator using an EFD at 0.23 mJ/mm<sup>2</sup> and 500 pulses/cm<sup>2</sup> of wound, with the frequency at 4 pulses per second (4 Hz). ESWT sessions were performed twice per week for a total of six treatments over 3 weeks. In the control group, HBOT was performed once a day, five sessions a week, resulting in a total of 40 treatments. All patients in both groups received basically the same local wound care protocol, which included wound cleansing and silver sulfadiazine cream application, with a possibility of administering antibiotic treatment. After 3 weeks, 57% of wounds in the ESWT and 25% of wounds in the HBOT groups were completely healed (<em>P</em> = 0.003). Wounds in 32% of ESWT and 15% of HBOT group were improved (<em>P</em> = 0.071). No significant differences in improvement of local blood flow perfusion were noted between groups (<em>P</em> = 0.245), but the change from baseline in the ESWT group was significant (<em>P</em> = 0.002). Histopathological examination of biopsy samples showed lower cell apoptosis and higher cell proliferation, concentration, and activity in the ESWT group, but no statistics were reported. No systemic or local neurovascular adverse events were noted.</p>
<p> A randomized, controlled, double-blind clinical study was conducted by Ottomann et al<sup>38</sup> among 44 burn patients with superficial second-degree BWs. The study participants were randomized to ESWT (n = 22) or no ESWT intervention (n = 22). All patients were blinded to treatment allocation and analyzed as intent-to-treat. Patient median total body surface area (TBSA) involved by thermal injury was 3% (range 1%–8%) in the ESWT and 4% (range 1%–50%) in the control group. Participants in the ESWT group were significantly older (average age 52.2 ± 16.6 years) than participants in the control group (average age 37.5 ± 13.3 years) (<em>P</em> = 0.002). A single session of ESWT was performed with a defocused electrohydraulic device using an EFD at 0.1 mJ/mm<sup>2</sup> and 100 pulses/cm<sup>2</sup> of BW area at a frequency of 5 Hz. Sterile USG gel was applied onto a sterile plastic drape placed over the wound, which also was covered with USG gel. The primary endpoint — reepithelialization &gt;95% — was assessed by an independent, blinded observer. All BWs were healed after an average 11.0 ± 2.4 days; 9.6 ± 1.7 days in the ESWT and 12.5 ± 2.2 days in the control group (<em>P</em> &lt;0.0005). Infections were noted in 9% of ESWT and 14% of control group patients.</p>
<p><a href="/files/owm/owm_july2014_taradaj_t5.jpg" rel="lightbox" title="Table 6"><img src="/files/owm/small_owm_july2014_taradaj_t5.jpg" style="float:right" /></a> <a href="/files/owm/owm_july2014_taradaj_t6.jpg" rel="lightbox" title="Table 5"><img src="/files/owm/small_owm_july2014_taradaj_t6.jpg" style="float:right" /></a> <strong>Evidence obtained from other clinical studies (see Table 5 and Table 6).</strong> Saggini et al<sup>39</sup> conducted a controlled clinical study among 40 patients with VLUs, DFUs, and TW. All study participants were allocated to either a SWC and ESWT group (n = 30 out of 32 wounds) or a SWC only control group (n = 10 out of 10 wounds). No general or local anesthesia or other injections were used during the ESWT treatment, which was performed with a focused electrohydraulic system using an EFD at 0.037 mJ/mm<sup>2</sup> and 100 pulses/cm<sup>2</sup> of each wound area at a frequency of 4 Hz. The ESWT protocol consisted of one session per 2 weeks, resulting in a total of four to 10 sessions. A single-layer sterile gauze was placed on the USG gel, which was applied to the wound surface and the ESWT applicator head. Researchers recorded the following results for the ESWT sessions and control procedures, respectively: complete wound closure 53.3% and 10.0%, reduced necrotic fibrin 30.7% and 12.5%, and post-treatment wound area decreased from 10.41 cm<sup>2</sup> to 2.03 cm<sup>2</sup> (<em>P</em> &lt;0.01). Additionally, the authors determined greater improvement in granulation tissue among 30.7% of ESWT recipients compared to worsening among 7.5% of patients from the control group (<em>P</em> &lt;0.01). Most improvements were noted following the ﬁrst four to six ESWT sessions. No complications or side effects such as microtraumatic effect, bleeding, hematomas, sarcomas, or painful sensations were documented after ESWT sessions.</p>
<p> Schaden et al<sup>40</sup> prospectively enrolled 208 patients with etiologically different nonhealing wounds: SW (n = 82), TW (n = 67), VLU (n = 14), PU (n = 7), AIU (n = 6), and BW (n = 7). ESWT was applied via defocused electrohydraulic generator using an average dosage of EFD at 0.01 mJ/mm<sup>2</sup> and 100 pulses/cm<sup>2</sup> depending on the wound area at a frequency of 5 Hz. An ESWT session was performed once every 2 weeks, resulting in a total of one to 10 treatment sessions. A plastic drape covered with sterile USG coupling gel was used after necrotic tissue was removed. ESWT was the primary wound therapy performed with adjunctive SWC management. Of the 176 patients who completed the study, 156 (88.6%) had completely healed wounds. Mean period of ESWT stimulation needed for complete epithelialization was 43.5 days. Complete wound closure was significantly associated with the wound area in 81.0% and 61.8% of the patients with ≤10 cm<sup>2</sup> and &gt;10 cm<sup>2</sup> wound area, respectively (<em>P</em> = 0.005). Also, complete tissue epithelialization was significantly associated with wound duration in 83.0% and 57.1% of completely healed participants with ≤1 month and &gt;1 month duration, respectively (<em>P</em> &lt;0.001). Wound epithelialization improved in 81.0% of acute and 56.3% of chronic wounds (<em>P</em> = 0.001). Researchers did not report any adverse events following ESWT.</p>
<p> In a clinical, observational, prospective pilot study by Arno et al<sup>41</sup> involving patients with acute BW &lt;5% TBSA (N = 15), participants were provided ESWT on the third and fifth postburn accident day. ESWT was performed with a defocused electrohydraulic machine using an EFD at 0.15 mJ/mm<sup>2</sup> and 500 pulses/cm<sup>2</sup> of BW area, with unspecified frequency values. ESWT sessions were provided twice a week, resulting in a total of two treatment sessions in sterile conditions, without anesthesia or antibiotics. Some potential adverse events — eg, bleeding, hematomas, petechiae, and painful sensations — were documented. Researchers documented 80% of patients completely healed after 3 weeks of ESWT treatment, but 15% required surgical debridement and grafting and 5% displayed hypertrophic scarring after burn healing. Additionally, blood perfusion levels in laser Doppler imaging were enhanced after a single session of ESWT (<em>P</em> value not reported). Authors did not describe any side effects or adverse events, and the patients tolerated ESWT well.</p>
<p> Wolf et al<sup>42</sup> performed an open, prospective clinical study among 282 patients with various chronic soft tissue wounds who received ESWT stimulation in conjunction with SWC procedures. Participants included 93 SW (36.1%), 83 TW (33.3%), 38 VLU (14.7%), 13 DFU (5%), 11 AIU (4.3%), nine PU (3.5%), and eight BW (3.1%) patients. ESWT was performed with a defocused electrohydraulic device using an EFD at 0.1 mJ/mm<sup>2</sup> and median number of 167 pulses/cm<sup>2</sup> at a frequency of 5 Hz. ESWT sessions were performed one to two times every 2 weeks, resulting in a total of &lt;10 treatment sessions. To improve skin contact, the USG sterile gel was placed on the wound surface and covered with a surgical drape. SWC was systematically continued in all patients after each ESWT session. Authors reported 24 participants lost to follow-up. The majority of patients (74.03%) demonstrated complete wound closure after SWC plus ESWT after a median time of 31.8 months and two treatment sessions. No side effects or tissue damage following ESWT were documented.</p>
<p> Fioramonti et al,<sup>43</sup> who published the first clinical case report, saw positive results of ESWT in the treatment of a VLU in a 63-year-old patient with chronic venous insufficiency (CVI) and two ulcers on the right leg (3 cm<sup>2</sup> on the external malleolar region and 8 cm<sup>2</sup> on the medial pretibial region) and one on the left leg (6 cm<sup>2</sup> on the medial pretibial region). Only the VLUs on the right leg were treated with ESWT; the left leg was designated the control and managed with SWC. ESWT was performed with a focused electrohydraulic source using an EFD at 0.037 mJ/mm<sup>2</sup> and median number of 100 pulses/cm<sup>2</sup> at a frequency of 4 Hz. ESWT sessions were provided once a week, amounting to a total of six treatment sessions. Complete VLU healing of the right extremity wound was reported after six ESWT treatment sessions and compared with a 6-week period of SWC on the left VLU, where healing was still incomplete. Researchers did not document any complications and adverse events after ESWT sessions.</p>
<p> The case report by Stieger et al<sup>44</sup> evaluated the efficiency of ESWT in a case of a 56-year-old patient with secondary lymphedema, class III morbid obesity, and a VLU of at least 6-years’ duration characterized by a severely fibrotic, partially fibrin-coated ulcer of 150 cm<sup>2</sup> total wound area exhibiting minimal granulation, severe perifocal reddening, and maceration that extended from the pretibial part of the right lower leg to the lateral calf. Various treatments had been provided, including surgical procedures, compression therapy, negative pressure therapy, and wound dressings. Sterile USG conducting gel was applied to a cleaned wound and covered with polyurethane film. To improve ESWT transmission, USG gel was applied on that film again. ESWT was performed with a defocused electromagnetic generator using an EFD at 0.25 mJ/mm<sup>2</sup> and 10 pulses/cm<sup>2</sup> at a frequency of 4 Hz to a total area of 200 cm<sup>2</sup> (150 cm<sup>2</sup> of VLU area plus the wound margins). ESWT sessions were performed once a week as an adjuvant therapy; SWC procedures remained unchanged for the duration. After five ESWT sessions, wound granulation and reepithelialization improved, and complete wound closure was observed after a total of 30 ESWT sessions. No adverse events or pain were reported during ESWT.</p>
<h3>Discussion</h3>
<p> The purpose of this study was to evaluate evidence of ESWT effectiveness in humans. Results of the systematic literature review suggest there is substantial published evidence documenting that ESWT application is safe and effective for the treatment of different etiologically soft tissue wounds.</p>
<p> In the analyzed studies, ESWT was used to facilitate healing of chronic DFU,<sup>33,34,37,39</sup> PU,<sup>36,40,42</sup> VLU,<sup>39,40,42-44</sup> and AIU wounds,<sup>40,42</sup> as well as acute wounds involving BW,<sup>38,40-42</sup> TW,<sup>39,40,42</sup> and SW resulting from CABG<sup>32</sup> or STSG procedures.<sup>35</sup> ESWT applied to soft tissue wounds produced a wide variety of positive results, including complete wound closure and reepithelialization,<sup>33-35,36-44</sup> improvement of blood flow perfusion,<sup>33,37,41</sup> enhancement of tissue granulation, reduction of necrotic fibrin tissue,<sup>39,44</sup> shortened period of wound treatment,<sup>35,38,43</sup> and decreased necessity for antibiotic treatment.<sup>32</sup></p>
<p> Better results were reported for patients who received additional ESWT treatment sessions in contrast to SWC alone,<sup>32,34,35,38,39,43</sup> HBOT concomitant to adjunctive SWC,<sup>33,37</sup> or sham ESWT sessions.<sup>38</sup> Most studies reported no or few adverse events or complications.<sup>32,33,35,37-44</sup> Adverse events and side effects documented following ESWT included signs of ulcer infections<sup>34,38</sup> and enlarged wounds with ischemic edges.<sup>36</sup></p>
<p> In most of the studies reviewed, ESWT treatment sessions were performed without hospitalization and without anesthesia.<sup>33,37,39,41,43</sup> Methodological similarities included ensuring sterile conditions and use of a sterile ultrasonic gel as contact medium and the use of a sterile barrier: a sterile USG gel was applied to a cleaned wound to improve transmission of acoustic ESWT waves and/or the wound was covered with sterile barrier in the form of cellulose<sup>33,37,39</sup> or plastic drape.<sup>32,34,35,38-40,44</sup> Also, the same USG gel was applied onto the drape as a medium to provide full skin contact. In many studies, the ESWT applicator head was placed directly over the surface of the wound<sup>32-44</sup> (see Figure 4).</p>
<p> All of the reviewed studies used low- and medium-energy ESWT treatment, with the shock waves generated with electrohydraulic<sup>33,35,36,38-43</sup> or electromagnetic sources.<sup>32,34,37,44</sup> Two types of ESWT generator heads were generally used: defocused<sup>35-38,40-42,44</sup> or focused.<sup>32-34,39,43</sup> The EFD in the studied cases was characterized by a range from 0.03 to 0.25 mJ/mm<sup>2</sup> (0.11 ± 0.07 mJ/mm<sup>2</sup>)<sup>34,44</sup> but the most regular value of EFD was 0.1 mJ/mm<sup>2</sup>.<sup>32,33,35,36,38,40,42</sup></p>
<p> The frequency was set at 4<sup>36,39,43,44</sup> or 5 pulses per second (Hz)<sup>32,37,38,40,42</sup>; however, a few of the studies did not describe that parameter.<sup>33-35,42</sup> In most studies, the number of pulses in a single ESWT session ranged from 10 to 500 pulses/cm<sup>2</sup> (206.4 ± 172.3 pulses/cm<sup>2</sup>),<sup>41,44</sup> but the most frequent value was 100 pulses/cm<sup>2</sup> of wound area.<sup>34,35,38-41,43</sup></p>
<p> According to the review of clinical research studies, in the case of chronic wounds ESWT sessions were typically once<sup>36,42-44</sup> or twice per week,<sup>34,37,41</sup> as well as once every 2 weeks.<sup>33,39,40,42</sup> The total number of treatment sessions ranged between three<sup>33,34</sup> and six.<sup>37,43</sup> However, in some studies ESWT therapy was continued for a longer period (10<sup>39,40,42</sup> to 30 sessions<sup>44</sup>). In studies that included patients who had presented with acute SWs, a single intraoperative session of ESWT treatment was applied.<sup>32,35</sup><a href="/files/owm/owm_july2014_taradaj_f5.jpg" rel="lightbox" title="Figure 5"><img src="/files/owm/small_owm_july2014_taradaj_f5.jpg" style="float:right" /></a> The average time of a single ESWT session was 1 to 3 minutes, depending on the size of the wound.<sup>34,36,39-42</sup> The duration of a single intraoperative ESWT session in the case of acute wounds ranged between 10<sup>32</sup> to 13 minutes.<sup>35</sup> An outline of ESWT application for wound treatment with regard to the methodological and practical issues, as well as biological effects and potential therapeutic properties, is presented in Figure 5.</p>
<h3>Conclusions</h3>
<p> The results of this literature review suggest ESWT can be used as an adjunct therapy for healing chronic and acute soft tissue wounds. Substantial supporting clinical evidence confirms ESWT utility and the range of positive results, such as completed wound closure and reepithelialization, enhanced tissue granulation, reduced necrotic fibrin tissue, improved blood flow perfusion and angiogenesis, reduced period of total wound treatment, and decreased necessity of antibiotic treatment.</p>
<p> Nevertheless, additional well-designed clinical studies and meta-analyses are necessary to investigate ESWT safety, efficacy, and cost-effectiveness in patients suffering from wide range of skin wounds. Despite the results obtained from well-designed studies showing positive wound healing outcomes, further studies should address methodological study shortcomings such as adequate methods of randomization, concealment of treatment allocation, and clear information about blinding, as well as inclusion of intent-to-treat and follow-up analysis.</p>
<p> Sham-controlled, randomized, multicenter, blinded clinical trials with the highest methodological quality and scientific data reliability are needed to ascertain ESWT efficacy and develop explicit evidence-based guidelines and recommendations. The results of this study show ESWT can be characterized as a noninvasive, painless, and safe physical treatment modality that seems beneficial in healing soft tissue wounds. In the future, ESWT may play an important role in wound care; however, evidence-based practical guidelines should be developed first.</p>
<h3>Acknowledgments</h3>
<p> The authors acknowledge this systematic review was prepared as a theoretical part of the project funded by the Polish National Science Centre allocated on the basis of decision no. DEC–2011/03/N/NZ7/00327.</p>
<p><em>Dr. Dymarek is a physical therapist and assistant, Department of Nervous System Diseases, University of Medicine in Wroclaw, Wroclaw, Poland. Dr. Halski is a physical therapist and Head of Physiotherapy, Institute of Public Higher Professional Medical School, Opole, Poland. Dr. Ptaszkowski is a physical therapist and assistant, Department of Gynecology and Obstetrics; Dr. Slupska is a physical therapist and assistant, Department of Physiotherapy; and Prof. Rosinczuk is a nurse and Head of Department of Nervous System Diseases, University of Medicine. Prof. Taradaj is a physical therapist, Trustee of the European Pressure Advisory Panel, and Head of Department of Physiotherapy Basics, Academy School of Physical Education, Katowice, Poland. Please address correspondence to: Prof. Jakub Taradaj, Department of Physiotherapy Basics, Academy School of Physical Education in Katowice, Mikolowska 72 A Street, 40-065 Katowice, Poland; email: <a href="mailto:j.taradaj@awf.katowice.pl">j.taradaj@awf.katowice.pl</a>.</em></p>
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<p>29. Davis TA, Stojadinovic A, Anam K, Amare M, Naik S, Peoples GE, et al. Extracorporeal shock wave therapy suppresses the early proinflammatory immune response to a severe cutaneous burn injury. <em>Int Wound J</em>. 2009;6(1):11–21. </p>
<p>30. Kuo YR, Wang CT, Wang FS, Yang KD, Chiang YC, Wang CJ. Extracorporeal shock wave treatment modulates skin fibroblast recruitment and leukocyte infiltration for enhancing extended skin-flap survival. <em>Wound Repair Regen</em>. 2009;17(1):80–87. </p>
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<p>34. Moretti B, Notarnicola A, Maggio G, Moretti L, Pascone M, Tafuri S, et al. The management of neuropathic ulcers of the foot in diabetes by shock wave therapy. <em>BMC Musculoskelet Disord</em>. 2009. doi: 10.1186/1471-2474-10-54. </p>
<p>35. Ottomann C, Hartmann B, Tyler J, Maier H, Thiele R, Schaden W, et al. Prospective randomized trial of accelerated re-epithelization of skin graft donor sites using extracorporeal shock wave therapy. <em>J Am Coll Surg</em>. 2010;211(3):361–367. </p>
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</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-65">Literature Review</a></div><div class="field-item odd"><a href="/topics/section-7">Feature</a></div></div></div>Fri, 11 Jul 2014 14:43:37 +0000hmpadmin2644 at http://www.o-wm.comhttp://www.o-wm.com/article/extracorporeal-shock-wave-therapy-adjunct-wound-treatment-systematic-review-literature#commentsManaging Severe Dermatitis Caused by Ileal Peristomal Leakage Using a Mushroom-type (de Pezzer) Catheter in Infants: A Case Serieshttp://www.o-wm.com/article/managing-severe-dermatitis-caused-ileal-peristomal-leakage-using-mushroom-type-de-pezzer-cat
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/2515">Volume 59 - Issue 12 - December 2013 ISSN 1943-2720</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-index field-type-text field-label-inline clearfix"><div class="field-label">Index:&nbsp;</div><div class="field-items"><div class="field-item even">Ostomy Wound Manage. 2013;59(12):26–31.</div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Seyed Abbas Banani, MD; and Seyed Javad Banani, MD</div></div></div><div class="field field-name-taxonomy-vocabulary-3 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Topics:&nbsp;</div><div class="field-items"><div class="field-item even">Case Study</div><div class="field-item odd">infants</div><div class="field-item even">Ileostomy</div><div class="field-item odd">Dermatitis</div><div class="field-item even">hyponatremia</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><h3>Abstract</h3>
<p> Skin damage secondary to peristomal leakage is a fairly common complication of ileostomies in infants. Traditional conservative measures, including skin barriers, ointments, and agents to reduce bowel movements, initially may be helpful but not in all patients. The purpose of this case series was to describe a new and relatively simple procedure to temporarily manage severe peristomal dermatitis caused by ileal peristomal leakage in infants.</p>
<!--break--><p>After obtaining informed consent from the parents, a mushroom-type (de Pezzer) catheter was inserted into the ileostomy of 11 1- to 4-month-old infants (seven males, four females) with severe peristomal dermatitis. Eight had total aganglionic colon (TAC), two had meconium ileus (cystic fibrosis), and one had meconium peritonitis due to bowel perforation proximal to ileal atresia. The severity of the peristomal dermatitis improved remarkably in all patients after 2 to 3 days. In eight patients, minimal (if any) dermatitis was noted within 5 to 7 days after tube insertion. Six patients who initially had poor weight gain (mean 345 g/month) developed acceptable weight gain (mean 648 g/month) (<em>P</em> &lt;0.03) within 2 to 4 months. In seven patients with TAC, the tube was maintained for 2 to 4 months until definitive pull-through procedure; in four other patients, the tube remained in place for 3 to 7 days as a step for preoperative build-up. None of the patients developed any complications. The procedure requires the presence of a pediatric or trained surgeon, and care must be taken to prevent iatrogenic damage. In this case series, an appropriate-size, mushroom-type (de Pezzer) catheter placed within the ileostomy was a practical mode for temporary control of ileal peristomal leakage that causes severe peristomal dermatitis in infants, particularly in those not responding to medical therapy. Larger studies are needed to develop evidence-based protocols of care for the prevention and management of ileostoma complications in infants.</p>
<p><strong>Potential Conflicts of Interest:</strong> none disclosed</p>
<h3>Introduction</h3>
<p> Ileostomy surgery in infants is a life-saving procedure in many situations, including Hirschsprung’s disease with total aganglionic colon (TAC) (dysmotile spastic colon due to congenital absence of ganglion cells in the rectum and colon), complex meconium ileus (cystic fibrosis), necrotizing enterocolitis, gastroschisis with ileal atresia, and in the presence of meconium or fecal peritonitis due to ileal perforation.<sup>1</sup> Despite its vital advantages in the latter situations, an ileostomy in this population is associated with a variety of management problems<sup>1</sup>; chemical, mechanical, and allergic dermatitis or skin excoriation around the stoma are the most frequent among its different complications.<sup>2-6</sup> Although some patients may respond temporarily to ordinary conservative treatment, such as application of skin barriers and low-potency topical steroids in mild to moderate peristomal dermatitis for few days and administration of agents to reduce bowel movements, further aggressive management might be needed in other situations, particularly those requiring ileostomy for several months, such as TAC.</p>
<p> The main function of the colon is to conserve fluid and sodium.<sup>7</sup> In ileostomy patients, such colonic function is lacking. Subsequently, owing to loose and high-output content of the ileostomy containing proteolytic enzymes, patients are prone not only to dehydration and hyponatremia, but also to irritant dermatitis.<sup>6,8</sup> Various dermatological problems occur in children and some adults. Other than chemical injury, this situation also may be due to mechanical destruction, infections, immunological reactions, or disease-related conditions.<sup>3</sup> According to Ratliff and Donovan’s prospective descriptive study,<sup>9</sup> the frequency of peristomal complications is highest among patients with ileal conduits and ileostomies. Approximately one third of the patients in Robertson et al’s case series<sup>10</sup> and 57% in Herlufsen et al’s series<sup>11</sup> had compromised skin around the ileostomy, 77% of which could be related to contact with stoma effluent. In the Jemec and Nybaek series,<sup>12</sup> more than one in three visits to ostomy nurses were due to peristomal skin problems. Prospective, descriptive studies<sup>6,13</sup> have shown many patients (79%) with ileostomy, regardless of age and underlying cause of stoma, will develop mild to moderate dermatitis. Furthermore, retrospective studies<sup>14,15</sup> have indicated severe episodes of peri-ileostomy dermatitis occur in 5% to 25% of patients.</p>
<p><a href="/files/owm/owm_december2013_banani_f1.jpg" rel="lightbox" title="Figure 1"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_f1.jpg" style="float:right" /></a> Regardless of its extent and patient age or size, peristomal dermatitis is managed mainly using a combination of skin barriers, different ointments, and most importantly, a pouching system (ie, a well-fitted ileostomy device) to prevent direct contact between the irritant bowel contents and the peristomal skin. However, in the authors’ experience, pouching systems for ileostomy in infants, in contrast to adults, are less efficient for fecal diversion. In other words, because of poor or partial appliance adherence in children, especially infants, ileal peristomal leakage occurs, and as expected the chance of problems around the ileostomy is higher as compared to adults. For the same reason, some infants may develop dermatitis extending to the unprotected ipsilateral groin (see Figure 1).</p>
<p> Furthermore, there is always a chance of superimposed fungal infection or candidiasis accompanying severe peristomal dermatitis or excoriation of skin at any age (including infants), aggravating the problem.<sup>1,2,4,6,9,16</sup> In addition, because of the physiologic cotransport phenomenon of sodium glucose, in the presence of hyponatremia, glucose cannot be absorbed normally. As a result, glucose concentration of the bowel content will increase, which subsequently gives rise to more frequent small bowel movements or osmotic diarrhea.<sup>8</sup> The latter problem cannot be overcome unless the low serum sodium concentration is corrected. Therefore, for a variety of reasons, these patients usually have frequent small bowel movements associated with poor feeding. Consequently, the patients are not only irritable and restless, but they also may develop dehydration, acid base imbalances, hyponatremia, and poor weight gain if not properly managed.</p>
<p> Despite the availability of different kinds of appliances, pouching systems, and skin barriers, stoma-related skin lesions are not uncommon.<sup>1,2,5,16</sup> Moreover, management of severe dermatitis around an ileostomy, especially when it is not responding to conservative therapy, remains a challenge. The purpose of this case series is to describe a new and relatively simple procedure to temporarily manage severe peristomal dermatitis caused by ileal peristomal leakage in infants. <a href="/files/owm/owm_december2013_banani_kp.jpg" rel="lightbox" title="Key Points"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_kp.jpg" style="float:right" /></a></p>
<h3>Catheter Insertion Technique</h3>
<p> An appropriately sized, mushroom-type (de Pezzer) catheter is selected, usually No. 22 or 24 for early infancy (up to 6 months of life). For better drainage, the nipple of the catheter is partially cut and, if necessary, its side holes are enlarged. The infant is sedated (the authors use hydroxyzine syrup 0.5 mL/kg 10 minutes before the procedure) in the operating theater or alternatively in the emergency room. Before insertion of the catheter by the pediatric or trained surgeon, the direction of the ileum for a few centimeters proximal to the stoma must be determined by a smooth-curved clamp to prevent iatrogenic bowel perforation. The widest part of the catheter then is folded on its longitudinal axis and clamped. The tube, while stretched to reduce its tip diameter, is held by the third to fifth fingers (usually the right hand). Once inserted for 3 to 4 cm, the tube is released and then de-clamped. To prevent catheter removal during withdrawal of the clamp, the catheter is held with a smooth forceps (in the left hand) introduced through the stoma. Owing to the self-holding nature of the catheter, suturing is not necessary. To prevent the chance of bowel obstruction, the tube (40 cm in length) is shortened to 12 to 15 cm to reduce resistance to outflow of bowel contents, after which it is connected either to an ostomy bag or a cost-effective ordinary plastic bag. Antifungal- and zinc oxide-containing ointment also is applied three to four times per day for another 5 to 6 days along with Vaseline® (EX-DOPAR, Sina Darou Lab Co, Iran) or vitamin A ointment twice daily for at least 1 week. To prevent detachment of the ileostomy, the catheter should not be inserted earlier than 3 weeks after construction of the ileostomy.</p>
<h3>Other Interventions</h3>
<p> As part of post-ileostomy medical management, to compensate for sodium loss and prevent metabolic acidosis, sodium bicarbonate (2 to 2.5 meq/kg/day in three to four divided doses) mixed with milk is given to all patients, regardless of peristomal condition, until the time of ileostomy closure. If necessary, a short course (5 to 7 days) of parasympatholytic agent (such as dicyclomine and, less frequently, belladona) for reduction of bowel movement (&gt;2/hour) also is administered. An infant ileostomy bag is not used in any patient because of availability problems, cost, or lack of appropriate size and secure fit. <a href="/files/owm/owm_december2013_banani_t1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_t1.jpg" style="float:right" /></a></p>
<h3>Methods</h3>
<p> <strong>Patients.</strong> From April 2003 through March 2012, outpatient infants (1 to 6 months old) with an ileostomy who exhibited signs of severe dermatitis unresponsive to conservative therapy were considered for the procedure. Complete inclusion/exclusion criteria are detailed in Table 1.</p>
<p> <strong>Procedure.</strong> A mushroom-type (de Pezzer) catheter was inserted by the senior author into the ileostomy (with dermatitis around) and care procedures described instituted.</p>
<p> The peristomal skin was photographed every 2 to 3 days during the first 10 days until alleviation or substantial improvement of the dermatitis (dry pink skin in the absence of gross inflammation). Monthly body weights were recorded for comparison of before and after the tube insertion weight. Serum sodium and potassium concentrations also were measured at the time of referral before the tube insertion, corrected if needed, and checked once more 3 to 4 weeks after the procedure. Measurement of ileostomy fluid loss was not performed quantitatively. However, patients’ parents were asked to report estimated frequency of small bowel movements (ie, defecations via ileostomy) during 24 hours for 2 to 3 days both before and after catheter insertion.</p>
<p> The procedure was approved by the ethics committee of Shiraz University of Medical Sciences. Before the procedure, parents were informed of its benefits and potential problems, after which written parental consent was obtained.</p>
<p> <strong>Data collection and analysis.</strong> Wilcoxon signed-ranks test was used for statistical analysis of the weight gain. A <em>P</em> value &lt;0.05 was considered statistically significant. Descriptive statistics of extent and severity of dermatitis was performed by gross appearance (inspection) of skin before and after catheter insertion. <a href="/files/owm/owm_december2013_banani_t2.jpg" rel="lightbox" title="Table 2"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_t2.jpg" style="float:right" /></a></p>
<h3>Results</h3>
<p> Eleven 1- to 4-month-old infants (seven males, four females) with an end or loop ileostomy and severe dermatitis (ie, circumferential, ≥1.5 cm from the edge of the stoma, inflamed, wet, and deeply red skin) underwent the procedure (see Table 2). Five patients had dermatitis extending up to near the ipsilateral groin (see Figure 1a). Ileostomy had been performed for the following reasons: TAC (eight patients, six distal ileostomy and two mid-ileostomy), complex meconium ileus (two, due to cystic fibrosis), and meconium peritonitis due to bowel perforation proximal to ileal atresia (one patient) (see Table 2). <a href="/files/owm/owm_december2013_banani_f2.jpg" rel="lightbox" title="Figure 2"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_f2.jpg" style="float:right" /></a> The severity of the peristomal dermatitis improved in all patients 2 to 3 days after the catheter was inserted. In eight patients, minimal if any dermatitis (ie, the skin appeared dry, non-inflamed, with almost normal skin color at the periphery of the stoma) was noted 5 to 7 days after insertion of the catheter (see Figures 1b, 2b, 3b). In addition, patients who had dermatitis near the ipsilateral groin showed marked improvement similar to healing of the peristomal skin lesion (see Figure 1). No relation was found between the initial extent of dermatitis and duration of time necessary for notable response to the procedure. There also was marked reduction in the number of defecations via ileostomy after tube insertion from 55 to 70 times/day before to 15 to 25 times/day following the procedure. Six patients with TAC who had poor weight gain (mean 345 [± 41] g/month, range 300 to 420 g/month) gained a significant amount of weight (mean 648 [± 57] g/month, range 600–750 g/month) thereafter (<em>P</em> &lt;0.03). <a href="/files/owm/owm_december2013_banani_f3.jpg" rel="lightbox" title="Figure 3"><img src="/files/owm/imagecache/thumbnails/owm_december2013_banani_f3.jpg" style="float:right" /></a> Although the potassium concentration was within normal range in all patients, hyponatremia (Na+ &lt;130 meq/L) was detected in three patients with TAC despite daily sodium bicarbonate (2–2.5 meq/kg) administration. However, once corrected, hyponatremia did not recur while receiving the same sodium bicarbonate dose until the time of closure of the ileostomy. Major complications, such as bowel erosion or detachment of the ileostomy, did not occur in any patients. In two restless patients with TAC, the tube was extruded two times (1 to 2 weeks after insertion) without evidence of obstruction. Reinsertion was performed with a larger size catheter and no additional extrusions occurred. To prevent recurrence of the dermatitis, in seven patients with TAC who were not yet ready for a pull-through operation, the catheters were maintained for 2 to 4 months until the time of definitive procedure, usually at the age of 4 to 6 months. In five of the latter group, the tubes were renewed every 4 to 6 weeks because of partial tube decay. The tubes in four other patients were in place for only 3 to 7 days as a step for preoperative build-up (see Table 2). Final procedures included a Martin/Duhamel pull-through or a total colectomy and partial proctectomy followed by ileomidrectal anastomosis with or without posterior anorectal myectomy. None of the patients developed wound infection at the site of ileostomy following its closure.</p>
<h3>Discussion</h3>
<p> In general, three different categories of complications may occur after ileostomy: anatomical (eg, prolapse, parastomal hernia, stenosis, retraction), physiological (eg, dehydration, hyponatremia), and dermatitis or skin excoriation around the stoma, which is the most common.<sup>6,9-12</sup> Dermatologic problems are far more similar among children and adults than the other two types of complications; as such, dermatologic-related information on ileostomy is not specific to infants/children. However, for a variety of reasons, such as irritant alkaline content of the ileal discharge,<sup>3,6</sup> frequency of small bowel movements, texture of skin, and lack of snug fit of the ostomy device, dermatitis around the ileostomy is more common in infants than adults.</p>
<p> Severe peristomal dermatitis at any age may be accompanied by superimposed fungal infection, which in turn aggravates the problem.<sup>1,2,4,6,9,16</sup> The main goal of the relatively simple procedure described in this study is to guide management of severe peristomal dermatitis in infants that has been shown to be unyielding to other modes of conservative therapy by preventing further direct contact of irritant small bowel contents to the skin around the ileostomy (see Figures 1b, 2b, 3b). In the authors’ experience, tube insertion into the ileostomy in the presence of severe dermatitis is highly effective, especially when infant pouching systems are not available or too costly. Regardless of the initial extent of severe dermatitis, the majority of the authors’ patients had remarkable improvement in a short period of time and almost complete healing occurred in approximately 1 week. In addition, some of the untoward side effects of the ileostomy, such as frequent defecations via ileostomy or poor weight gain, also improved.</p>
<p> Selecting an appropriate catheter size is crucial to achieving these goals. The mushroom-type (de Pezzer) catheter (original length = 40 cm) should not be too long to cause bowel obstruction, nor should it be too narrow to cause leakage around the tube or facilitate extrusion. In the authors’ experience, an appropriate tube length (approximately 12 to 15 cm) and size (usually No. 22 or 24 in early infancy) produces adequate resistance to outflow of the bowel contents without obstruction or significant leakage around the tube.</p>
<p> Although the number of small bowel movements before and after catheter insertion was estimated by the parents, the noted difference was substantial (55 to 70 per day versus 15 to 25 per day) and may be the result of partial stasis or slow transit time. Subsequently, there would be longer time for bowel contents to be absorbed. In other words, the outflow resistance created by the catheter causes delayed emptying and, at least to some extent, would lead to increased absorption and acceptable weight gain. However, the latter also may be partly related to healed dermatitis obviating irritability, restlessness, and to some extent, catabolic state. Therefore, a combination of factors — ie, the healing process and reduced loss of fluid and electrolytes presumably associated with improved absorption — may support an anabolic state and explain the statistically significant increase in weight gain (<em>P</em> &lt;0.03). Although this procedure was performed in infants with positive response, owing to the loose and watery nature of ileal contents, it also might be useful in older children and even adults.</p>
<p> The need for daily replacement of sodium bicarbonate in infants with an ostomy (particularly an ileostomy) cannot be overemphasized. Patients with an ileostomy require 6 to 10 mmol/kg (equivalent to 6 to 10 meq/kg) of sodium per day.<sup>8</sup> With ordinary feeds, infants receive 2 to 4 mmol/kg of sodium per day.<sup>8</sup> Thus, the sodium deficit may be estimated at 4 to 6 mmol/kg. To prevent this complication, sodium bicarbonate 4 to 6 meq/kg/day, as suggested by Sacher et al,<sup>8</sup> should be given daily in divided doses until the ileostomy is closed. Although the maintenance dose (2 to 2.5 meq/kg/day) of sodium given to the authors’ patients was about half of the recommended dose suggested by Sacher et al,<sup>8</sup> none of their patients developed hyponatremia after its correction and ileostomy tube insertion. This also may have been due to outflow resistance created by the tube providing longer time for ileal contents, including sodium, to be absorbed.</p>
<h3>Limitations</h3>
<p> An important limitation of the procedure is that, due to potential complications such as iatrogenic bowel perforation, catheter insertion should be performed by an expert or trained surgeon. To prevent detachment of the ileal stoma, the procedure should not be performed earlier than 3 weeks after construction of the ileostomy. In the presence of failure to thrive or poor weight gain, because of poor wound healing, the surgeon should be very cautious during tube insertion. The results reported here only describe a small sample of patients; more extensive research to help standardize care is needed.</p>
<h3>Conclusion</h3>
<p> In this case series, inserting an appropriate-size, mushroom-type (de Pezzer) catheter inside the ileostomy as a temporary measure for fecal diversion and control of ileal peristomal leakage in infants was found to be a practical method to manage severe peristomal dermatitis. Following the procedure, the dermatitis resolved. In addition, weight gain and hyponatremia were observed to improve in patients not responding to conservative therapy. This procedure may be considered for infants with ileostomies and skin problems, especially in settings where an alternative pouching system is not readily available. Further studies on the safety, effectiveness, and efficacy of this method are warranted.</p>
<h3>Acknowledgment</h3>
<p> The authors are most grateful to Dr. Hassanzadeh for his statistical analysis.</p>
<p> <em>Dr. SA Banani is a Professor of Pediatric Surgery and Academic Member, Shiraz University of Medical Sciences (SUMS), Department of Pediatric Surgery, Shiraz, Iran. Dr. SJ Banani is a General Practitioner and Clinical Research Assistant at University of British Columbia, Vancouver, BC, Canada. Please address correspondence to: Seyed Javad Banani, MD, 2306-918 Cooperage Way, Vancouver, BC, Canada V6B 0A7; email: <a href="mailto:sjavadbanani@alumni.ubc.ca">sjavadbanani@alumni.ubc.ca</a>.</em></p>
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<p>10. Robertson I, Leung E, Hughes D, Spiers M, Donnelly L, Mackenzie I, et al. Prospective analysis of stoma-related complications. <em>Colorectal Dis</em>. 2005;7(3):279–285.</p>
<p>11. Herlufsen P, Oslen AG, Carlsen B, Nybaek H, Karlsmark T, Laursen TN, et al. Study of peristomal skin disorders in patients with permanent stomas. <em>Br J Nurs</em>. 2006;15(16):854–862.</p>
<p>12. Jemec GB, Nybaek H. Peristomal skin problems account for more than one in three visits to ostomy nurses. <em>Br J Dermatol</em>. 2008;159(5):1211–1212.</p>
<p>13. Moon CM, Meffert JJ. Periostomy dermatitis: a novel therapeutic approach. <em>Skinmed</em>. 2002;1(1):60–61.</p>
<p>14. Shellito PC. Complications of abdominal stomal surgery. <em>Dis Colon Rectum</em>. 1998;1(12):1562–1572.</p>
<p>15. Husain SG, Cataldo TE. Late stomal complications. <em>Clin Colon Rectal Surg</em>. 2008;21(1):31–40. 16. Burch J, Sica J. Common peristomal skin problems and potential treatment options. <em>Br J Nurs</em>. 2008;17(17):S4–S8.</p>
</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-63">Case Report</a></div><div class="field-item odd"><a href="/topics/section-7">Feature</a></div></div></div>Wed, 11 Dec 2013 19:58:05 +0000hmpadmin2517 at http://www.o-wm.comhttp://www.o-wm.com/article/managing-severe-dermatitis-caused-ileal-peristomal-leakage-using-mushroom-type-de-pezzer-cat#commentsA Descriptive Survey Study on the Effect of Age on Quality of Life Following Stoma Surgeryhttp://www.o-wm.com/article/descriptive-survey-study-effect-age-quality-life-following-stoma-surgery
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/2515">Volume 59 - Issue 12 - December 2013 ISSN 1943-2720</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-index field-type-text field-label-inline clearfix"><div class="field-label">Index:&nbsp;</div><div class="field-items"><div class="field-item even">Ostomy Wound Manage. 2013;59(12):16–23.</div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Selina K. Wong, BSc; Pang Y. Young, MD; Sandy Widder, MD, MHA, FRCSC; and Rachel G. Khadaroo, MD, PhD, FRCSC, on behalf of the Acute Care and Emergency Surgery (ACES) Group of the University of Alberta, Canada</div></div></div><div class="field field-name-taxonomy-vocabulary-3 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Topics:&nbsp;</div><div class="field-items"><div class="field-item even">Ileostomy</div><div class="field-item odd">Colostomy</div><div class="field-item even">Quality of Life</div><div class="field-item odd">aged</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><h3>Abstract</h3>
<p> The number of operative procedures involving the creation of an intestinal stoma is likely to increase as the population ages. Understanding the role of age on postoperative outcomes such as quality of life (QoL) and self-efficacy is critical to developing appropriate supportive strategies. A descriptive survey study was conducted among 18 patients (11 men seven women, age range 47 to 90 years) who had an intestinal ostomy created during a 3-year period at the University of Alberta Hospital in Edmonton, Alberta, Canada.</p>
<!--break--><p>The Stoma Quality of Life Survey and a self-efficacy survey examining self-care, activities of daily living, and instrumental activities of daily living were administered. Patient records were obtained through a retrospective chart review; of the 57 patients identified, 18 were still alive, had not undergone stoma reversal, were cognitively competent, and agreed to participate. Seven patients were &lt;65 years old and 11 were ≥65 years old. Of those, four patients had their stoma since 2009, four patients since 2010, and 10 patients since 2011. Although older patients had more comorbidities and higher mortality following the surgery (46.1% for patients &gt;65 versus 26.1%, for patients &lt;65 years old), no statistically significant difference was found between the two groups for stoma-associated QoL and self-efficacy scores. In patients who had stoma surgery in 2011, older patients on average had higher QoL scores (65.21 versus 61.87, maximum score 100, <em>P</em> = 0.56), but lower self-efficacy scores (32.50 versus 35.25, maximum score 40, <em>P</em> = 0.50). These findings are similar to previously reported study results. However, the small study sample size limits analysis of the variables that may affect QoL in stoma patients. This study supports the need for additional prospective studies to help clinicians develop effective support strategies.</p>
<p> <strong>Potential Conflicts of Interest:</strong> This study was funded by the M.S.I. Foundation and the Canadian Institute of Health Research Health Professional Summer Student Award.</p>
<h3>Introduction</h3>
<p> The growing number of North America’s elderly, combined with increasing life expectancy, has led to a greater number of older patients undergoing gastrointestinal (GI) surgery. These abdominal surgeries can require intestinal resections leading to a discontinuity of the GI tract. In many instances, this necessitates the creation of an intestinal stoma. Common indications for stomas include malignancy, infection, obstruction, and perforation. Receiving an ostomy is a life-changing experience that has both mental and physical long-term effects. According to multiple retrospective and prospective studies, patients with ostomies have to cope not only with daily maintenance of the stoma, but also with the associated changes in body image,<sup>1-4</sup> sexual function,<sup>5-7</sup> social activities,<sup>8</sup> and sleep.</p>
<p> Regardless of age, the challenges faced by ostomy patients can affect many aspects of well-being. Likely, older patients strive to enjoy active lives, have anxieties regarding the effects of having a stoma, and perceive quality of life (QoL) to be extremely important, similar to their younger counterparts. Although studies have examined the psychological and physical effects of having a stoma, few have explored the effect of age on QoL and ability to manage the stoma. The relatively few retrospective studies<sup>12,13</sup> that have examined the relationship between age and stomas suggest that while older age alone should not be reason to deny patients ostomy surgery, older patients are affected differently than younger patients following stoma surgery.</p>
<p> Compared to their younger counterparts, the geriatric population is unique due to several additional factors that impact health. Elderly patients may be frail, have comorbid conditions, present as emergency cases,<sup>14</sup> and have cognitive and/or physical impairments.<sup>15</sup> In several retrospective studies<sup>14,16</sup> focusing on outcomes following colorectal surgery, older patients tended to have longer lengths of stay, more frequent postoperative complications, and a significant reduction of overall survival in comparison to the younger population. Therefore, elderly patients are considered high-risk surgical populations and are more likely to undergo intestinal diversion through an ostomy, as opposed to primary anastamosis, following a resection.<sup>17</sup></p>
<p><a href="/files/owm/owm_december2013_khadaroo_kp.jpg" rel="lightbox" title="Key Points"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_kp.jpg" style="float:right" /></a> Understanding how age affects QoL following stoma surgery is important to help healthcare workers acknowledge and competently address the needs of older patients. To determine whether older patients (≥65 years) are more likely to have lower perceived QoL and decreased self-efficacy compared to their younger (&lt;65 years) counterparts following stoma surgery, a retrospective review of patient records was conducted, and the effect of age on patient QoL, self-efficacy, and management after stoma surgery (financial and need for assistance with stoma care) was assessed prospectively using The Stoma Quality of Life Survey and a self-efficacy survey.</p>
<h3>Methods</h3>
<p> <strong>Study design.</strong> This study consisted of two components: 1) a retrospective chart review and 2) administration of QoL and self-efficacy surveys to living patients identified from the chart review. A local institutional infection control surveillance database consisting of all clean-contaminated colon surgery cases was used to identify cases for retrospective review. All patients requiring the creation of an ostomy at the University of Alberta Hospital, in Edmonton, Alberta, Canada between January 2009 and December 2011 were identified and a retrospective chart review conducted.</p>
<p> Inclusion criteria were all patients over the age of 18 years undergoing the creation of an ileostomy or colostomy for all diagnoses. Elective and urgent cases were included. Only clean-contaminated cases were included in the institutional surveillance database, and as such, were the only case classification included for study. The Centers for Disease Control and Prevention (CDC) guidelines were used for the definition of clean-contaminated cases, which are defined as operative wounds in which the respiratory, alimentary, genital, or urinary tract is entered under controlled conditions and without unusual contamination.</p>
<p> Following the chart review, the following exclusion criteria were applied to identify participants for the surveys: ostomy reversal at the time of the study, cognitive impairment at the time of follow-up, and death at time of the study. Ostomy reversal was an exclusion for survey participation to eliminate recall bias in assessing stoma-related outcomes. Living patients were contacted by telephone. Information about the study was provided and oral consent was obtained from the patients. Ethics approval was granted by the Human Research Ethics Board (HREB) at the University of Alberta.</p>
<p> <strong>Procedure.</strong> Background characteristics of all patients who met study criteria were obtained from the detailed chart review. This retrospective data collection included patient demographics and clinical characteristics at the time of ostomy creation (age, American Society of Anesthesiologists [ASA] score, comorbidities), and operative characteristics (type of ostomy, operative diagnosis, urgency, reversal, and year of surgery/time since surgery). The ASA score ranging from 1 to 6 (where 1 = a healthy patient and 6 = a declared brain-dead patient whose organs are being retrieved for donor purposes) was used to grade the physical status of patients at the time of the operation. Additional perioperative data were collected on postoperative outcomes, such as overall mortality. All demographic data were de-identified following chart review.</p>
<p> A mini mental test (the four-item Abbreviated Mental Test, AMT4)<sup>19</sup> was used to screen willing participants to ensure their capacity to complete the surveys. Subsequently, the questionnaires were administered over the telephone by a medical student during the same encounter to those who were willing and cognitively competent.</p>
<p> Three questionnaires were administered. First, patients were asked general questions regarding demographics as well as living arrangement (Are you currently living with anyone?), stoma-related finances (How much money do you spend on your stoma monthly? &lt;$50, $50 to 100, or &gt;$100), and assistance with stoma care (Do you get help taking care of your stoma? Always, sometimes, or never). Second, participants completed the Stoma-QoL,<sup>8</sup> a validated questionnaire developed by Prieto et al, which focuses on four domains: sleep, sexual activity, relations to family/close friends, and relations to those other than family/close friends. The Stoma-QoL consists of 20 statements (eg, I become anxious when the pouch is full), each scored from 1 to 4 (where 1 = always and 4 = not at all) for a total raw score out of 80, and then converted to a global score between 0 and 100. The Stoma-QoL was administered in English. Because activities of daily living are an integral aspect of postoperative outcomes, a third survey examining self-efficacy was developed to directly address patient ostomy management.</p>
<p><a href="/files/owm/owm_december2013_khadaroo_f1.jpg" rel="lightbox" title="Figure 1"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_f1.jpg" style="float:right" /></a> The self-efficacy questions were formulated by the researchers to focus on the subcategories self-care, basic activities of daily living (BADL), and instrumental activities of daily living (IADL). BADL focuses on fundamental self-care, such as feeding and personal hygiene; IADL emphasizes activities needed for independent community functioning, such as housework and shopping. The survey consisted of 10 questions, each scored from 1 to 4 (maximum score = 40) based on how confident the patient was in performing a specific task (for example, preventing leakages or keeping the stoma site clean, where 1 = not confident and 4 = extremely confident) (see Figure 1). The self-efficacy questionnaire was an instrument designed by the researchers and was not tested for validity or reliability. For both the self-efficacy and Stoma-QoL surveys, higher scores represented higher self-efficacy and QoL, respectively. <a href="/files/owm/owm_december2013_khadaroo_t1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_t1.jpg" style="float:right" /></a></p>
<h3>Results</h3>
<p> <strong>Patient demographics.</strong> Two hundred, forty-one (241) clean-contaminated colon surgeries, performed between 2009 and 2011, were identified using the institutional infection control database. Of these, 57 patients (age range 26 to 91 years old) underwent the creation of an intestinal ostomy. Of these, 35 living patients were eligible to participate in the QoL and self-efficacy surveys; three were excluded because of ostomy reversal. The remaining 32 patients were contacted: one refused participation, one lacked the mental capacity to participate, and 12 were lost to follow-up. Mortality rate since time of surgery was higher in the older versus younger age group (47.1% versus 26.1%, <em>P</em> = 0.17). Ultimately, 18 patients (length of time since ostomy ranging from 6 months to 3 years) completed the surveys. Patient demographics are presented in Table 1.</p>
<p> Older patients had more comorbidities at the time of surgery than younger patients, particularly diabetes (17.6% versus 4.3%, <em>P</em> = 0.22), coronary artery disease (32.4% versus 13.0%, <em>P</em> = 0.12), hypertension (50.0% versus 30.4%, <em>P</em> = 0.17), chronic obstructive pulmonary disease (20.6% versus 4.3%, <em>P</em> = 0.13), and renal failure (8.8% versus 4.3%, <em>P</em> = 0.64). Obesity (body mass index [BMI] ≥30) was more prevalent in the younger group (43.5% versus 26.5%, <em>P</em> = 0.25). More older patients than younger patients had an ASA score &gt;2 (82.4% versus 65.2%, <em>P</em> = 0.21). Higher ASA scores represent more severe comorbid disease and lower functional physical status.</p>
<p><a href="/files/owm/owm_december2013_khadaroo_f2.jpg" rel="lightbox" title="Figure 2"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_f2.jpg" style="float:right" /></a> <a href="/files/owm/owm_december2013_khadaroo_t2.jpg" rel="lightbox" title="Table 2"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_t2.jpg" style="float:right" /></a> <strong>Surgical characteristics (see Table 2).</strong> Colostomies were more common than ileostomies in both age groups (64.7% versus 78.3%, older versus younger patients, respectively; <em>P</em> = 0.38). Older patients were more likely to have the stoma created during an emergency surgery than younger patients (50.0% versus 21.7%, <em>P</em> = 0.052). Cancer was the most common indication for surgery in both older and younger patients (73.5% versus 43.5%, respectively) (see Figure 2). Other indications for surgery included immobility/incontinence, colostomy prolapse, diverticular disease, sigmoid volvulus, rectal prolapse, and colonic polyps. Older patients had significantly lower rates of sacral decubitus ulcers (2.9% versus 21.7%, <em>P</em> = 0.006) and a trend toward lower rates of inflammatory bowel disease (0% versus 8.7%, <em>P</em> = 0.06). Three patients, all in the &gt;65 years of age group, underwent ostomy reversal surgery.</p>
<p><a href="/files/owm/owm_december2013_khadaroo_f3.jpg" rel="lightbox" title="Figure 3"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_f3.jpg" style="float:right" /></a> <strong>Self-efficacy and QoL.</strong> No statistically significant differences were found in self-efficacy scores between older and younger patients (older versus younger patients, 32.57 [range 21–40] versus 32.45 [range 15–40] out of a maximum score of 40, <em>P</em> = 0.98). For the Stoma-QoL, average scores were higher in older than in younger patients, although the difference was not statistically significant (63.94 versus 56.18 out of a maximum score of 100, <em>P</em> = 0.14) (see Figure 3).</p>
<p> To exclude the effect of length of time that patients had ostomies, the 2011 cohort of patients (N = 10) was analyzed as a subgroup. The 2011 group was the largest subset of patients from the 3-year period, and these patients had ostomies for the shortest period of time. The 2011 cohort also was divided into two age groups (age &lt;65 and ≥65 years) and examined for the effect of age on self-efficacy and QoL. In the 2011 subset, older patients had lower self-efficacy (average 32.50 versus 35.25, <em>P</em> = 0.50) but higher QoL scores (average 65.21 versus 61.87, <em>P</em> = 0.56) than their younger counterparts. <a href="/files/owm/owm_december2013_khadaroo_f4.jpg" rel="lightbox" title="Figure 4"><img src="/files/owm/imagecache/thumbnails/owm_december2013_khadaroo_f4.jpg" style="float:right" /></a></p>
<p> The majority of both older and younger patients never required assistance with daily stoma care (63.6% of older and 57.1% of younger patients). Among patients who required assistance, older patients were more likely to always need help (36.4% versus 14.3%) as opposed to younger patients who tended to report needing only occasional help (28.5%) (see Figure 4). After taking health insurance coverage into consideration, younger patients were more likely than older patients to spend more than $50 per month on ostomy supplies (57.1% versus 27.3%, <em>P</em> = 0.21).</p>
<h3>Discussion</h3>
<p> The objective of this retrospective chart review and descriptive survey study was to assess the effect of age on self-efficacy and QoL following ostomy surgery. Elderly patients are considered to be at a higher operative risk primarily due to their lower physiologic reserve and higher incidence of comorbidities.<sup>20</sup> This is an important problem to address due to the rapidly aging demographics of the Western world.</p>
<p> As expected, the older group of patients (age ≥65) had a higher number of comorbidities than the younger patients (age &lt;65). Although this finding was not statistically significant, a trend toward higher incidence of comorbidities in the older age group was noted, with rates of diabetes and chronic obstructive pulmonary disease almost four times higher in the older age group. The overall health differences between groups also are reflected in the higher mortality rate in the older age group (47.1% versus 26.1%). This is corroborated by numerous studies that show older age groups have significantly higher mortality following colorectal surgery due to comorbidities.<sup>16,21,22</sup> A retrospective study by Grosso et al<sup>23</sup> found that patients &gt;65 years of age not only presented with more comorbidities than younger patients, but they also subsequently had a higher incidence of postoperative complications and lower 3- and 5-year survival rates.</p>
<p> It might be expected that the elderly group of patients would have lower QoL and self-efficacy, but in this study, no differences were found. In fact, QoL scores in older patients following stoma surgery may be equal to, if not higher than, those of younger patients. These findings are consistent with a retrospective study done by Stryker et al<sup>15</sup> comparing the QoL of older versus younger patients with conventional ileostomies. They found that in all categories of QoL assessment, older patients scored as well or higher than the younger patients. Although greater difficulty in daily management was found to be more prevalent among the older age group members, they did not experience more occupational or activity restrictions. A retrospective study by Scarpa et al<sup>24</sup> involving 34 patients with ileostomies following colorectal cancer showed that QoL scores were consistent in three age groups (&lt;50, 50 to 70, &gt;70 years of age), but older patients required additional assistance taking care of their stomas. These findings underscore the observation that although older patients require more assistance with the care of their stomas (for example, changing appliances), this does not necessarily translate to a lower QoL.</p>
<p> The self-efficacy questionnaire designed for this study measured three key domains: self-care, BADL, and IADL. Most questions were targeted at measuring patients’ confidence in their ability to care for their stoma (for example, change appliances, prevent leakage, take baths/showers, and be physically active). In this study’s subset of patients who underwent stoma surgery in 2011, the older population had lower self-efficacy scores. This finding may be expected as a result of the deterioration in visual acuity, skin integrity, gastrointestinal health, and joint mobility issues that arise with age.<sup>15</sup> Wu et al’s<sup>25</sup> cross-sectional correlation study of 96 stoma patients (mean duration of having a stoma 26.2 months) recruited from two acute care hospitals in Hong Kong similarly found that older patients tend to have lower self-efficacy than younger age groups. However, despite older patients scoring similar to or lower than their younger counterparts on the self-efficacy survey, their QoL was not correspondingly decreased. These results suggest that in stoma patients, QoL may be affected by more factors than stoma care self-efficacy alone. Marquis et al<sup>26</sup> found that patients who were satisfied with the care they received and who perceived their stoma care nurses as having a genuine interest in them had the highest QoL index postoperatively.</p>
<p> This study was designed primarily to compare older and younger patients in terms of overall self-efficacy and QoL and did not measure other physiologic and psychosocial domains that likely also account for differences in QoL that are not explained by self-efficacy alone. For example, Bekkers et al<sup>5</sup> prospectively studied psychosocial adaptation following stoma surgery and found that age is a significant characteristic that affects psychosocial rehabilitation. Following ostomy formation, older patients had more problems adapting in the sexuality domain and experienced more social environmental problems (such as leisure time activities and holidays).</p>
<p> Research also has shown that changes in QoL over time differ between older and younger patients. A prospective pilot study by Ma et al<sup>27</sup> followed changes in QoL of 49 patients aged 23 to 86 years old over a 12-month period. Participants completed a QoL questionnaire preoperatively and at 6 and 12 months postoperatively. In the context of physical and mental functioning, older patients showed less improvement in QoL over a 12-month period than the younger patients and also showed no further improvement after 6 months. A prospective study examining impact of age on QoL of 519 rectal cancer patients by Schmidt et al<sup>28</sup> similarly has shown that the QoL of older patients does not return to baseline even 2 years after the stoma procedure, suggesting physical functioning of older patient is more permanently affected by the surgery.</p>
<p> There are several possible explanations for the current findings that older patients fare equally as well or potentially better than younger patients after stoma surgery. Because stoma surgery is such a drastic, body-altering procedure, body image is one of the most significant and common patient concerns.<sup>1-4,29</sup> Furthermore, body image is strongly linked to an individual’s sense of sexual attractiveness1 and comfort with social interactions.<sup>2</sup> Consequently, ostomy surgery can impact partner interactions<sup>30</sup> and sexual functioning.<sup>31</sup> In the current patient population, older patients reported greater comfort with their bodies, less concern regarding their sexual adequacy, and positive relationships with their spouse/family/friends. This corresponds to Orsini’s<sup>13</sup> long-term cancer survivorship study, which demonstrated that sexual functioning and enjoyment were significantly lower in younger patients compared to the normative population and not significantly different in older patients. Comfort with body image may contribute to the higher QoL in the current older age group. Older patients also may be more likely to have established relationships and an occupation or be retired.</p>
<p> Nichols and Riemer<sup>32</sup> examined the effect of stabilizing forces on postsurgical recovery and found that patients with occupational stability where ostomy surgery did not lead to a change in work habit reported higher life satisfaction scores. In addition, a stable spouse/partner relationship (patients who were married before surgery and remained married after surgery) also predicted higher life satisfaction scores, as did having a stable and supportive family. Because family is often a significant source of support and positive interactions for patients, a family or spouse’s ability to adapt and demonstrate a positive emotional response plays a significant role in improving an ostomate’s self-esteem and ability to adapt to the effects of the surgery.<sup>33,34</sup> Altschuler et al’s<sup>35</sup> descriptive study, branching from a parent study measuring QoL in cancer survivors with ostomies, found that withdrawal of husbands’ or partners’ support has a significant impact on psychosocial adjustment following ostomy surgery. In the majority of cases (17 out of 22), women with high or low health-related QoL scores corresponded to a positive or negative description regarding husband/partner support respectively. These variables were not measured in the current study.</p>
<h3>Limitations</h3>
<p> Bias may have been introduced due to the small sample size and the retrospective nature of the study. Only 18 of the 57 patients identified from the surgical database could be surveyed. In addition, the older age group was predominantly male, which may limit generalizability to the overall patient population. Ideally, the study would prospectively identify patients undergoing stoma creation and have standardized follow-up periods. By doing so, the effect of age alone on QoL could be better isolated and distinguished from any changes in QoL that result from patients having had more time to adapt to their stoma. The self-efficacy survey measure used in this study was not validated, further limiting generalizability.</p>
<p> Finally, bias could be introduced by the variable time interval between ostomy creation and survey administration. The largest cohort of patients (2011 subset) had ostomies for the shortest period of time. Subgroup analysis did not show differences in the observed trends in self-efficacy and QoL; however, time can potentially affect these outcomes. A prospective study design would help to negate these limits but requires a large sample size due to anticipated drop-outs. Because 47% of the older population and only 26% of the younger age group died before the time the survey was conducted, survivorship bias may have caused higher self-efficacy and QoL scores in the older age group.</p>
<h3>Conclusion</h3>
<p> This retrospective review and descriptive survey study provides data supporting the need for a larger prospective study examining how age affects postoperative stoma-associated outcomes, including self-efficacy and QoL. Although older patients seem to score lower in terms of self-efficacy within 1 year after surgery, results from this study suggest their QoL is equal to, if not higher than, that of younger patients. Because older patients are physiologically and psychologically unique from their younger counterparts, understanding the effect of an ostomy on their QoL is crucial to addressing their needs. This knowledge is essential for the effective allocation of healthcare resources, understanding which patient populations would most benefit from pre- and postoperative support, and determining the most useful types of support.</p>
<h3>Acknowledgment</h3>
<p> The authors are grateful to the University of Alberta’s Acute Care and Emergency Surgery (ACES) group and Ms. Yvonne Tul for their support in this research. ACES Group members include Ronald Brisebois, MD, FRCSC; Klaus Buttenschoen, MD; Kamran Fathimani MD, FRCSC; Stewart M. Hamilton, MD, MSc, FRCSC; Rachel G. Khadaroo, MD, PhD, FRCSC; Gordon M. Lees, MD, FRCSC; Todd McMullen, MD, PhD, FRCSC; William Patton, MD, CCFP(EM), FCFP; Mary Van Wijngaarden-Stephens, MD, FRCSC; J. Drew Sutherland, MD, FRCSC; Sandy Widder, MD, MHA, FRCSC; and David C. Williams, MD, MSc, FRCSC. The authors also thank enterostomal therapy nurses, Sandra Allen, RN, ET; Sandra Bressmer, RN, ET, BScN; and Sharon Goodhelpsen, RN, ET for the excellent care they provide for their patients.</p>
<p> <em>Ms. Wong is a medical student, Faculty of Medicine and Dentistry; Dr. Young is a surgical resident, Division of General Surgery, Department of Surgery; Drs. Widder and Khadaroo are General Surgeons, Division of General Surgery, Department of Surgery, University of Alberta, Edmonton, Alberta, Canada. Please address correspondence to: Dr. Rachel G. Khadaroo, Department of Surgery, 2D Walter C. Mackenzie Centre, 8440-112 St NW, Edmonton, AB T6G 2B7 Canada; email: <a href="mailto:khadaroo@ualberta.ca">khadaroo@ualberta.ca</a>.</em></p>
<p> </p>
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<p>7. Brown H, Randle J. Living with a stoma: a review of the literature. <em>J Clin Nurs</em>. 2005;14(1):74–81.</p>
<p>8. Prieto L, Thorsen H, Juul K. Development and validation of a quality of life questionnaire for patients with colostomy or ileostomy. <em>Health Qual Life Outcomes</em>. 2005;3(1):62.</p>
<p>9. Charua-Guindic L, Benavides-Leon CJ, Villanueva-Herrero JA, Jimenez-Bobadilla B, Abdo-Francis JM, Hernandez-Labra E. Quality of life in ostomized patients. <em>Cirugia y Cirujanos</em>. 2011;79(2):149–155.</p>
<p>10. Dabirian A, Yaghmaei F, Rassouli M, Tafreshi MZ. Quality of life in ostomy patients: a qualitative study. <em>Patient Prefer Adherence</em>. 2010;5:1–5.</p>
<p>11. Baldwin CM, Grant M, Wendel C, Hornbrook MC, Herrinton LJ, McMullen C, et al. Gender differences in sleep disruption and fatigue on quality of life among persons with ostomies. <em>J Clin Sleep Med</em>. 2009;5(4):335–343.</p>
<p>12. Manceau G, Karoui M, Werner A, Mortensen NJ, Hannoun L. Comparative outcomes of rectal cancer surgery between elderly and non-elderly patients: a systematic review. <em>Lancet Oncol</em>. 2012;13(12):e525–e36.</p>
<p>13. Orsini RG, Thong MS, van de Poll-Franse LV, Slooter GD, Nieuwenhuijzen GA, Rutten HJ, et al. Quality of life of older rectal cancer patients is not impaired by a permanent stoma. <em>Eur J Surg Oncol</em>. 2013;39(2):164–170.</p>
<p>14. Bosshardt TL. Outcomes of ostomy procedures in patients aged 70 years and older. <em>Arch Surg</em>. 2003;138(10):1077–1082.</p>
<p>15. Stryker SJ, Pemberton JH, Zinsmeister AR. Long-term results of ileostomy in older patients. <em>Dis Colon Rectum</em>. 1985;28(11):844–846.</p>
<p>16. Bufalari A, Giustozzi G, Burattini MF, Servili S, Bussotti C, Lucaroni E, et al. Rectal cancer surgery in the elderly: a multivariate analysis of outcome risk factors. <em>J Surg Oncol</em>. 2006;93(3):173–180.</p>
<p>17. Lidor AO, Schneider E, Segal J, Yu Q, Feinberg R, Wu AW. Elective surgery for diverticulitis is associated with high risk of intestinal diversion and hospital readmission in older adults. <em>J Gastrointest Surg</em>. 2010;14(12):1867–1873.</p>
<p>18. Horan TC, Andrus M, Dudeck MA. CDC/NHSN surveillance definition of health care-associated infection and criteria for specific types of infections in the acute care setting. <em>Am J Infect Control</em>. 2008;36(5):309–332.</p>
<p>19. Swain DG, Nightingale PG. Evaluation of a shortened version of the Abbreviated Mental Test in a series of elderly patients. <em>Clin Rehabil</em>. 1997;11(3):243–248.</p>
<p>20. Turrentine FE, Wang H, Simpson VB, Jones RS. Surgical risk factors, morbidity, and mortality in elderly patients. <em>J Am Coll Surg</em>. 2006;203(6):865–877.</p>
<p>21. Boyd JB, Bradford B Jr, Watne AL. Operative risk factors of colon resection in the elderly. <em>Ann Surg</em>. 1980;192(6):743–746.</p>
<p>22. Greenburg AG, Saik RP, Pridham D. Influence of age on mortality of colon surgery. <em>Am J Surg</em>. 1985;150(1):65–70.</p>
<p>23. Grosso G, Biondi A, Marventano S, Mistretta A, Calabrese G, Basile F. Major postoperative complications and survival for colon cancer elderly patients. <em>BMC Surg</em>. 2012;12(suppl 1):S20.</p>
<p>24. Scarpa M, Barollo M, Polese L, Keighley MR. Quality of life in patients with an ileostomy. <em>Minerva Chir</em>. 2004;59(1):23–29.</p>
<p>25. Wu HK, Chau JP, Twinn S. Self-efficacy and quality of life among stoma patients in Hong Kong. <em>Cancer Nurs</em>. 2007;30(3):186–193.</p>
<p>26. Marquis P, Marrel A, Jambon B. Quality of life in patients with stomas: the Montreux Study. <em>Ostomy Wound Manage</em>. 2003;49(2):48–55.</p>
<p>27. Ma N, Harvey J, Stewart J, Andrews L, Hill AG. The effect of age on the quality of life of patients living with stomas: a pilot study. <em>ANZ J Surg</em>. 2007;77(10):883–885.</p>
<p>28. Schmidt CE, Bestmann B, Kuchler T, Longo WE, Kremer B. Impact of age on quality of life in patients with rectal cancer. <em>World J Surg</em>. 2005;29(2):190–197.</p>
<p>29. Sideris L, Zenasni F, Vernerey D, Dauchy S, Lasser P, Pignon JP, et al. Quality of life of patients operated on for low rectal cancer: impact of the type of surgery and patients’ characteristics. <em>Dis Colon Rectum</em>. 2005;48(12):2180–2191.</p>
<p>30. Manderson L. Boundary breaches: the body, sex and sexuality after stoma surgery. <em>Soc Sci Med</em>. 2005;61(2):405–415.</p>
<p>31. Ho VP, Lee Y, Stein SL, Temple LK. Sexual function after treatment for rectal cancer: a review. <em>Dis Colon Rectum</em>. 2011;54(1):113–125.</p>
<p>32. Nichols TR, Riemer M. The impact of stabilizing forces on postsurgical recovery in ostomy patients. <em>J Wound Ostomy Continence Nurs</em>. 2008;35(3):316–320.</p>
<p>33. Gloeckner MR. Partner reaction following ostomy surgery. <em>J Sex Marital Ther</em>. 1983;9(3):182–190.</p>
<p>34. Dyk RB, Sutherland AM. Adaptation of the spouse and other family members to the colostomy patient. <em>Cancer</em>. 1956;9(1):123–138.</p>
<p>35. Altschuler A, Ramirez M, Grant M, Wendel C, Hornbrook MC, Herrinton L, et al. The influence of husbands’ or male partners’ support on women’s psychosocial adjustment to having an ostomy resulting from colorectal cancer. <em>J Wound Ostomy Continence Nurs</em>. 2009;36(3):299–305.</p>
</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-7">Feature</a></div></div></div>Wed, 11 Dec 2013 19:51:14 +0000hmpadmin2516 at http://www.o-wm.comhttp://www.o-wm.com/article/descriptive-survey-study-effect-age-quality-life-following-stoma-surgery#commentsTreatment of a diabetic hallux ulcer with ultraportable negative pressure wound therapy: a case study http://www.o-wm.com/content/treatment-diabetic-hallux-ulcer-ultraportable-negative-pressure-wound-therapy-case-study
<div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><h3>Kristine Nemes, DPM; and Robert Robertson, RN, MSN</h3>
<p><i>Seton Medical Center - San Francisco Center for Advanced Wound Care<br />
Daly City, CA</i></p>
<p> The increasing incidence of diabetes throughout the world will result in a correlational increase in diabetic sequelae such as diabetic foot ulceration.<sup>1</sup> Approximately 20.8 million Americans currently live with diabetes and an estimated 333 million adults will be diagnosed by 2025.<sup>1</sup> Substantial evidence has been published supporting the use of negative pressure wound therapy (NPWT) as a safe and effective adjunctive modality in the treatment of diabetic foot ulcers (DFUs), including several prospective randomized controlled trials.<sup>2-5 </sup></p>
<p><a href="/files/owm/notes_figs1&amp;2.jpg" rel="lightbox" title="Figures 1 &amp; 2"><img src="/files/owm/imagefield_thumbs/notes_figs1%262.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> One of the more common and complex locations for DFUs is the plantar surface of the toe.<sup>6</sup> Use of NPWT for the treatment of wounds in this location traditionally has been challenging, in part due to the small diameter of these wounds. Creating and maintaining an airtight seal in this anatomic location can further be complicated by the wound’s proximity to joints, which inherently have curved surfaces that intermittently move. Traditional NPWT devices that utilize electric pumps may not be ideally suited for these types of smaller-sized wounds due to the configuration of the dressings and size of the pumps. </p>
<p> The SNaP® Wound Care System (Spiracur, Sunnyvale, CA), an ultraportable nonelectrically powered NPWT device, has indications and contraindications for use similar to electrically powered systems — ie, removal of small amounts of exudate from chronic, acute, traumatic, subacute, and dehisced wounds, ulcers (such as diabetic or pressure), and surgically closed incisions. This NPWT system utilizes a specialized hydrocolloid dressing, which affords improved flexibility to achieve an airtight seal for challenging anatomical locations, as well as a
</p><p><a href="/files/owm/notes_fig3&amp;table1.jpg" rel="lightbox" title="Figure 3 &amp; Table 1"><img src="/files/owm/imagefield_thumbs/notes_fig3&amp;table1.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> Head-to-head randomized controlled trial data for chronic lower extremity wounds between this device and the electrically powered V.A.C.® Therapy device (KCI, San Antonio, TX) demonstrate no differences in wound healing outcomes or complications.<sup>7</sup> In addition, several other studies<sup>8-11</sup> have shown that the SNaP device can be both effective and cost-effective in treating diabetic wounds. </p>
<h3>Case Report </h3>
<p> <b>Presentation and assessment.</b> Mr. H is a 52-year-old man with a 10-year history of diabetes mellitus. He arrived in the emergency room (ER) with the onset of fever and chills within a 24-hour period. His medical history and physical revealed an ulcer on his left hallux that had been present for 9 months. He reported the ulcer first appeared as a blister from a pair of tight-fitting shoes. Previous treatments included daily silver sulfadiazine dressing changes and weekly debridements. He reported the ulcer had extended to bone for approximately 3 months. He stopped his doctor visits when he lost his insurance 3 weeks before this ER visit.</p>
<p> Testing revealed Mr. H had a white count of 13,200/µL and a left shift. He had a sedimentation rate of 55 mm/hour. A lower extremity ultrasound ruled out deep vein thrombosis (DVT). On exam, his vascular status was intact but his protective sensation bilaterally was absent to the ankles. The left hallux ulcer had thick overlying hyperkeratotic tissue and purulent drainage. There was significant edema of the hallux with mild erythema without warmth. </p>
<p><a href="/files/owm/notes_figs4&amp;5.jpg" rel="lightbox" title="Figures 4 &amp; 5"><img src="/files/owm/imagefield_thumbs/notes_figs4&amp;5.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> <b>Treatment.</b> Mr. H was treated overnight in the ER with vancomycin HCl and piperacillin/tazobactam. His wound cultures grew light growth methicillin-sensitive <i>Staphylococcus aureus</i> (MSSA), rare growth <i>Morganella morganii</i>, and rare growth <i>Bacteroides fragilis</i>. One of two blood cultures done in the ER were positive for <i>B. fragilis</i>. An MRI was performed that revealed a small focal osteomyelitis at the distal tuft of the distal phalanx of the hallux. </p>
<p> An aggressive excisional bedside debridement of the ulcer and bone was performed with a #15 blade scalpel, forceps, and rongeur in the ER. The remaining bone was firm to touch. After debridement, the ulcer measured 13 mm x 10 mm x 21 mm (length x width x depth) and probed to the distal phalanx of the hallux. Mr. H was discharged from the ER to home with wet-to-moist packing strip dressing changes three times a day and oral levofloxacin (500 mg) daily. He was further instructed to be nonweightbearing.</p>
<p> Nine days after his initial presentation into the ER, Mr. H was seen for follow-up at the wound care center. His ulcer post-debridement measured 8 mm x 9 mm x 20 mm (length x width x depth) and continued to probe to firm bone (see Figure 1). He was started on the portable, nonelectrically powered NPWT system, continued on levofloxacin, and allowed to be weight-bearing in a postoperative shoe with a crest pad under the hallux and second toe to offload the ulcer (see Figure 2). The NPWT placement technique is described in Figure 3 and Table 1.</p>
<p> After 4 weeks of treatment with the NPWT device, the oral antibiotic was discontinued per recommendation of an infectious disease consult. At week 5 (see Figure 4), NPWT was discontinued due to the small size of wound and Apligraf (Organogenesis, Canton, MA) was applied, followed by Mepitel nonadherent dressing (Mölnlycke, Switzerland) and Contreet foam (Coloplast, Denmark). Mr. H continued to use a postoperative shoe and crest pad. At follow-up 1 week post-Apligraf application, the ulcer was completely epithelialized. Mr. H was followed for an additional 2 months at increasing intervals and the ulcer remained healed (see Figure 5).</p>
<p> <b>Prognosis.</b> Mr. H was extremely satisfied with the NPWT treatment. He reported the device did not interfere with his normal daily activities, was never noticed in social situations, and did not disrupt his sleep. He experienced no discomfort from the device, neither during dressing changes nor while the negative pressure was activated.</p>
<p> As with most new technologies, there is a learning curve to applying the NPWT dressing and obtaining a seal that is minimal with relatively flat anatomical surfaces (eg, the pretibial area) but increases with anatomical curvature. The clinician needed 58 minutes to apply Mr. H’s initial dressing — he was one of the first patients we treated with this<br />
<b>NPWT system.</b> The time needed decreased to an average of 7 minutes (range 3–10 minutes) in subsequent applications. </p>
<h3>Discussion </h3>
<p> Diabetic ulcers occur on the toes usually related to trauma, footwear issues, and nail pathologies.<sup>12</sup> In neuropathic feet, these ulcers often go unnoticed and can quickly probe to bone. Topical treatments not packed into the wounds commonly will result in superficial closure without granulation deep in the ulcer. In our experience, this closure can result in deep infection, perhaps because bacteria are enclosed. When this occurs, the ulcer may worsen and aggressive treatment must be initiated. These ulcers require excisional debridement, including infected bone. If the damage from infection is severe enough, amputation may be necessary; however, in our experience amputation often can be avoided through aggressive debridement. Soft, necrotic bone is removed through the ulcer using appropriate instrumentation until a good healthy bleeding base is left and hard bone is palpated. At this point, the standard of care for bone infection is 4 to 6 weeks of appropriate systemic antibiotic therapy, guided by bone culture results. If bone is not involved, soft tissue infections are typically treated with antibiotics for ~2 weeks. Decisions relating to advanced wound care are rendered by the treating practitioner.<sup>13 </sup></p>
<p> The most basic wound care for deep, small diameter ulcers consists of wet-to-moist packing with packing strips soaked in normal saline changed multiple times per day. In our experience, this can be very labor-intensive for patients and caregivers. Other options for packing include calcium alginate strips, which are removed and repacked every 1 to 3 days. Calcium alginate works well in heavily draining ulcers, but in our experience often can dry out an ulcer that needs a moist environment. Advanced therapies involving bioengineered dressings and skin substitutes also can be applied deep into the wound if no infection exists; however, it is difficult to apply a single layer in small-diameter ulcers without folding the skin substitute on top of itself. In our past experience, NPWT typically would have been avoided in these types of ulcers. The ability to get a seal with a stiff conduit is challenging when the toe is involved; once the seal is obtained, it is difficult to maintain when the toe moves. If the seal is obtained and maintained, the next challenge is for a patient to carry the negative pressure device, which leads from a toe up to a bag they must carry around. This is by no means impossible, but it is cumbersome for patients, particularly if they work or have balance issues. </p>
<p> The new alternative NPWT device is designed for small diameter (
</p><h3>Conclusion</h3>
<p> NPWT has an important role in the treatment of DFUs. In our experience, it is a preferred method of treating ulcers that probe to or have exposed bone. Electric-powered negative pressure therapy devices on the market are reported to increase granulation tissue, decrease bacterial load, and cover exposed tendon and bone in larger ulcers, but have certain limitations relevant to smaller ulcers commonly seen in our clinics. The gauze and hydrocolloid dressing combination of the nonelectric NPWT system allows for packing into deep but small-diameter ulcers and facilitates use on ulcers typically deemed unsuitable for this modality due to the ulcer location or size. This system can help minimize the impact of NPWT on daily activities and provides a convenient, practical way to deliver NPWT. </p>
<h3>References</h3>
<p>1. Wu SC, Armstrong DG. Clinical outcome of diabetic foot ulcers treated with negative pressure wound therapy and the transition from acute care to home care. <i>Int Wound J</i>. 2008;5 (suppl 2):10–16.</p>
<p>2. Blume PA, Walters J, Payne W, Ayala J, Lantis J. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: a multicenter randomized controlled trial. <i>Diabetes Care</i>. 2008;31(4):631–636.</p>
<p>3. Armstrong DG, Lavery LA. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. <i>Lancet</i>. 2005;366(9498):1704–1710.</p>
<p>4. Eginton MT, Brown KR, Seabrook GR, Towne JB, Cambria RA. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds. <i>Ann Vasc Surg</i>. 2003;17(6):645–649.</p>
<p>5. Xie X, McGregor M, Dendukuri N. The clinical effectiveness of negative pressure wound therapy: a systematic review. <i>J Wound Care</i>. 2010;19(11):490–495.</p>
<p>6. Murdoch DP, Armstrong DG, Dacus JB, Laughlin TJ, Morgan CB, Lavery LA. The natural history of great toe amputations. <i>J Foot Ankle Surg</i>. 1997;36(3):204–208; discussion 256.</p>
<p>7. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparison of negative pressure wound therapy with an ultraportable mechanically powered device vs. traditional electrically powered device for the treatment of chronic lower extremity ulcers: a multicenter randomized-controlled trial. <i>Wound Repair Regen</i>. 2011;19(2):173–180.</p>
<p>8. Lerman B, Oldenbrook L, Eichstadt SL, Ryu J, Fong KD, Schubart PJ. Evaluation of chronic wound treatment with the SNaP wound care system versus modern dressing protocols. <i>Plast Reconstr Surg</i>. 2010;126(4):1253–1261.</p>
<p>9. Lerman B, Oldenbrook L, Ryu J, Fong KD, Schubart PJ. The SNaP Wound Care System: a case series using a novel ultraportable negative pressure wound therapy device for the treatment of diabetic lower extremity wounds. <i>J Diabetes Sci Technol</i>. 2010;4(4):825–830.</p>
<p>10. Hutton DW, Sheehan P. Comparative effectiveness of the SNaP Wound Care System. <i>Int Wound J</i>. 2011;8(2):196–205.</p>
<p>11. Fong KD, Hu D, Eichststadt BS, et al. Initial clinical experience using a novel ultraportable negative pressure wound therapy device. <i>WOUNDS</i>. 2010;22 (9):230–236.</p>
<p>12. Armstrong DG, Lavery LA. Diabetic foot ulcers: prevention, diagnosis and classification. <i>Am Fam Phys</i>. 1998;57(6):1325–1328.</p>
<p>13. Frykberg RG, Zgonis T, Armstrong DG, et al. Diabetic foot disorders. A clinical practice guideline (2006 revision). <i>J Foot Ankle Surg</i>. 2006;45(5 suppl):S1–S66.</p>
<p><i>This article was not subject to the Ostomy Wound Management peer-review process.</i></p>
</div></div></div>Tue, 12 Apr 2011 20:30:06 +0000hmpadmin1662 at http://www.o-wm.comVolume 57 - Issue 3 - March 2011http://www.o-wm.com/content/volume-57-issue-3-march-2011
<div class="field field-name-field-issue-date field-type-text field-label-above"><div class="field-label">Journal Date:&nbsp;</div><div class="field-items"><div class="field-item even">March 2011</div></div></div><div class="field field-name-field-volume-number field-type-number-integer field-label-above"><div class="field-label">Volume Number:&nbsp;</div><div class="field-items"><div class="field-item even">57</div></div></div><div class="field field-name-field-issue-number field-type-text field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even">3</div></div></div><div class="field field-name-field-publication-date field-type-date field-label-above"><div class="field-label">Publish Date:&nbsp;</div><div class="field-items"><div class="field-item even"><span class="date-display-single">Friday, March 4, 2011</span></div></div></div>Fri, 04 Mar 2011 18:27:16 +0000hmpadmin1618 at http://www.o-wm.comHealth-related Quality of Life and Self-Esteem in Patients with Diabetic Foot Ulcers: Results of a Cross-sectional Comparative Study http://www.o-wm.com/content/health-related-quality-life-and-self-esteem-patients-diabetic-foot-ulcers-results-cross-sect
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/1618">Volume 57 - Issue 3 - March 2011</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Luiz Carlos de Meneses, MD, MS; Leila Blanes, RN, PhD; Daniela Francescato Veiga, MD, PhD; Heitor Carvalho Gomes, MD, PhD; and Lydia Masako Ferreira, MD, PhD
</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><h3>Index: <i>Ostomy Wound Management</i> 2011;57(3):36–43.</h3>
<p><b>Key Words:</b> <a href="http://www.o-wm.com/search/google?cx=012264238924260504643%3Apmtdys-7if4&amp;cof=FORID%3A11&amp;query=cross-sectional+comparative+study&amp;sa.x=0&amp;sa.y=0&amp;sa=Search1&amp;form_build_id=form-e46acc0ff21be90cce48a13e62e43173&amp;form_token=cc67fa5dfd946a24550730ebf5645955&amp;form_id=google_cse_searchbox_form" target="_blank">cross-sectional comparative study</a>, <a href="http://www.o-wm.com/search/google?cx=012264238924260504643%3Apmtdys-7if4&amp;cof=FORID%3A11&amp;query=diabetes+mellitus&amp;sa.x=0&amp;sa.y=0&amp;sa=Search1&amp;form_build_id=form-97d8899ca27679a3163d6fdf5bc4f41a&amp;form_token=cc67fa5dfd946a24550730ebf5645955&amp;form_id=google_cse_searchbox_form" target="_blank">diabetes mellitus</a>, <a href="http://www.o-wm.com/search/google?cx=012264238924260504643%3Apmtdys-7if4&amp;cof=FORID%3A11&amp;query=diabetic+foot+ulcer&amp;sa.x=0&amp;sa.y=0&amp;sa=Search1&amp;form_build_id=form-b5012534f37091c6b4337cf2bc20f328&amp;form_token=cc67fa5dfd946a24550730ebf5645955&amp;form_id=google_cse_searchbox_form" target="_blank">diabetic foot ulcer</a>, <a href="http://www.o-wm.com/search/google?cx=012264238924260504643%3Apmtdys-7if4&amp;cof=FORID%3A11&amp;query=quality+of+life&amp;sa.x=0&amp;sa.y=0&amp;sa=Search1&amp;form_build_id=form-92ad895e2781172f0f7351bad1e17d53&amp;form_token=cc67fa5dfd946a24550730ebf5645955&amp;form_id=google_cse_searchbox_form" target="_blank">quality of life</a>, <a href="http://www.o-wm.com/search/google?cx=012264238924260504643%3Apmtdys-7if4&amp;cof=FORID%3A11&amp;query=self-esteem&amp;sa.x=0&amp;sa.y=0&amp;sa=Search1&amp;form_build_id=form-24073b4231f238033882ff739b3f241b&amp;form_token=cc67fa5dfd946a24550730ebf5645955&amp;form_id=google_cse_searchbox_form" target="_blank">self-esteem</a></p>
<h3>Abstract</h3>
<p> To evaluate health-related quality of life (HRQoL) and self-esteem in patients with diabetic foot ulcers (DFUs), a cross-sectional, comparative study was conducted among 35 consecutive patients with diabetes mellitus (DM) attending outpatient clinics in Pouso Alegre, Brazil. Fifteen (15) patients with and 20 without a DFU participated in the study. Demographic variables were obtained and HRQoL and self-esteem were assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Rosenberg Self-Esteem Scale. In both groups, 80% of patients were women. Average age did not differ significantly between the DFU and control groups (average 56 [SD 8.42] and 52 years [SD 6.68], respectively) but disease duration was significantly longer (<i>P</i> P = 0.043), role physical (<i>P</i> = 0.003), social functioning (<i>P</i> = 0.022), and role emotional (<i>P</i> = 0.001). Self-esteem scores were similar in both groups. The results of this study confirm that patient HRQoL is negatively affected by the presence of a DFU. Wound prevention programs for patients with DM may help reduce the scope of this problem while DFU treatment programs that include psychological support may improve patient QoL.</p>
<!--break--><p>
<b>Potential Conflicts of Interest:</b> none disclosed</p>
<p> Diabetes mellitus (DM) is a major public health problem with increasing incidence, prevalence, and associated costs. DM is associated with complications that affect productivity, quality of life (QoL), and longevity. Estimates show that 15% of the patients with DM will develop at least one foot ulcer in their lifetime.<sup>1,2</sup></p>
<p><a href="/files/owm/blanes_keypoints.jpg" rel="lightbox" title="Key Points"><img src="/files/owm/imagecache/thumbnails/blanes_keypoints.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> Foot ulcers are among the most common complications of type 2 DM, often preceded by various disorders that affect the skin, nerves, joints, muscles, and arteries of the foot, causing the development of the so-called “diabetic foot”<sup>2</sup> — ie, a complex clinicopathological condition that increases the risk of ulceration, impairment, disability, early retirement, lower limb amputation, and mortality.<sup>3</sup> In the US, diabetic foot ulcers are responsible for more than half of all nontraumatic amputations of the lower limbs, corresponding to 56% to 83% of the estimated 125,000 lower extremity amputations performed annually.<sup>4,5</sup></p>
<p> The presence or history of a foot ulcer has a large impact on physical functioning and mobility and affects patient QoL. <sup>6-8</sup> Interest in QoL as a clinical assessment and economic model variable has increased substantially.9,10 Patient QoL plays an important role in the development of health services<sup>11-14</sup>; QoL studies in patients with DM and foot ulcers may help improve prevention and treatment protocols of care. <sup>6,15,16 </sup></p>
<p> The purpose of this study was to assess and compare health-related quality of life (HRQoL) and self-esteem of patients with DM with and without foot ulcers.</p>
<h3>Methods and Procedures</h3>
<p> This cross-sectional comparative study was approved by the Research Ethics Committee at the Sapucaí Valley University (UNIVÁS), MG, Brazil. After a full explanation of the study was provided, written informed consent was obtained from all participants.</p>
<p> <b>Participants.</b> DM patients with a diabetic foot ulcer (DFU) (study group) and patients with DM without ulcers (control group), all 30 to 70 years of age, were consecutively selected for study participation at the outpatient clinics of Samuel Libânio University Hospital (HCSL) and the City Center for Diabetes Education (CEMED), MG, Brazil. Excluded from study participation were patients who were hospitalized, had a history of or were recommended to undergo a lower limb amputation, or had uncontrolled systemic diseases (eg, systemic arterial hypertension, cardiopathies, and collagen and rheumatic diseases). </p>
<p> All patients underwent a clinical and physical examination performed by a physician before being assessed by the research nurses. Patients with DM and controlled comorbidities were eligible to participate after receiving appropriate treatment(s). </p>
<p> <b>Variables.</b> Demographic variables and clinical characteristics (name, gender, age, race, educational level, diabetes duration) were assessed and recorded after informed consent was obtained at the start of the study. </p>
<p> <b>HRQoL.</b> HRQoL was assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) questionnaire, which had been translated into Portuguese, culturally adapted, and validated for Brazil.<sup>10</sup> There is no single overall score for the SF-36 questionnaire; instead, it contains one comparative item assessing changes in health over the past year and 35 items grouped into eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health) assessing the patient’s perception of health over the last 4 weeks. Scores on each dimension range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status. Each domain is evaluated and analyzed separately. </p>
<p> <b>Self-esteem.</b> Self-esteem was assessed using the Rosenberg self-esteem scale (UNIFESP-EPM), which was translated and validated for use in Brazil by Dini et al.<sup>13</sup> This is a 10-item measure in which the total score ranges from 0 to 30, with lower scores indicating higher self-esteem. The Brazilian version of the Rosenberg self-esteem scale has been shown to be a valid, reliable, and reproducible measure of self-esteem.<sup>13</sup></p>
<p> The first author of the present study administered the paper-pencil questionnaires. Because of the low educational level of the study population, an interview approach was used. Each multiple-choice question and respective alternative answers were read aloud exactly as written, as many times as needed, and the investigator recorded the responses. Care was taken not to introduce any bias and not to answer any question on the behalf of the patient. </p>
<p> <b>Data.</b> Data were entered into Excel® spreadsheets and statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS) release 17.0 for Windows (SPSS Inc., Chicago, IL).</p>
<p> Pearson’s chi-square test was used to compare the frequency distribution of categorical variables between groups. Fisher’s exact test was used for expected values
</p><p> Because gender distribution differed between groups, the non-parametric Mann-Whitney test was used at a significance level of 0.05 to determine if this variable had any effect on HRQoL and self-esteem scores. The Mann-Whitney test also was used for the comparison of SF-36 domain scores, self-esteem scores, and disease duration. Statistical significance was set at <i>P</i> ≤0.05. </p>
<h3>Results</h3>
<p> The control group consisted of 20 patients with DM without ulcers (80% women, 20% men, <i>P</i>
</p><p> The study group comprised 15 patients with DM and foot ulcers (80% men, 20% women, <i>P</i> P = 0.05). </p>
<p> Caucasian patients predominated in both the study (86.7%) and control (90%) groups; no significant differences in race were found between groups (<i>P</i> &gt;0.999). Also, no significant differences were noted in educational level between groups (<i>P</i> = 0.483); 8.6% of the total sample was illiterate and 65.7% had completed an elementary school education only.</p>
<p><a href="/files/owm/blanes_table1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/imagecache/thumbnails/blanes_table1.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> Significant differences between groups were found in the mean scores of the following SF-36 domains: physical functioning, role physical, social functioning, and role emotional, indicating that patients with foot ulcers had a lower HRQoL than patients without ulcers. In all SF-36 domains, the mean scores for patients with foot ulcers were lower than those for patients without ulcers (see Table 1). </p>
<p> No differences in self-esteem between groups were observed (see Table 2).<br />
No significant differences between genders were found in the following SF-36 domains: role physical (RP), social functioning (SF), and role emotional (RE). On average, women had higher HRQoL scores than men. Self-esteem scores were similar for both groups (see Table 3). </p>
<p><a href="/files/owm/blanes_table2.jpg" rel="lightbox" title="Table 2"><img src="/files/owm/imagecache/thumbnails/blanes_table2.jpg" align="right" vspace="4" hspace="4" /></a></p>
<h3>Discussion</h3>
<p> Diabetic foot ulcers cause pain and changes in lifestyle and QoL that may render the patient unable to perform normal activities. These ulcers are associated with high socioeconomic costs due to amputations, early retirement, loss of work capacity in the working-age group, work absenteeism, and hospital and medical costs.<sup>17-20</sup></p>
<p> In Brazil, approximately 5 million people have DM; of those, 50% are unaware that they have the disease.<sup>19</sup> Type 1 DM affects about 10% of this population. Among persons who know they have the disease, 90% have type 2 DM and 2% of type 2 DM patients have associated complications.<sup>19</sup> No estimates of the number of individuals with diabetes-related wounds are available in Brazil.<sup>21-23</sup></p>
<p><a href="/files/owm/blanes_table3.jpg" rel="lightbox" title="Table 3"><img src="/files/owm/imagecache/thumbnails/blanes_table3.jpg" align="right" vspace="4" hspace="4" /></a></p>
<p> The direct cost of DM ranges between 2.5% and 15% of the country’s annual healthcare expenditures, depending on prevalence rates and level of services provided. Annual direct DM-associated costs are estimated to range from $0.8 billion in Argentina to $2 billion in Mexico and $3.9 billion in Brazil.<sup>22,23</sup></p>
<p> DFUs are among the most common diabetes-related complications and are characterized by the presence of lesions on the feet caused by neurological (70% to 100% of cases) and vascular factors (10% of cases). DFU is a chronic complication that occurs (on average) 10 years after disease onset; it is the leading cause of hospital admissions among patients with DM. Patients with DFUs have a length of stay 59% longer than patients with DM without ulcers.<sup>5,23-27</sup></p>
<p> In the present study, exclusion criteria comprised indication for amputation of the lower limbs or previous amputation, associated uncontrolled systemic diseases, and hospitalization, factors that by themselves could compromise QoL or self-esteem.<sup>6,10,15,24</sup></p>
<p> The study group mean age was approximately 50 years, characterizing an adult but not elderly population that was already suffering from diabetes-related problems. The results of this study confirm that the presence of a DFU restricts mobility and negatively affects QoL and self-esteem. Most patients in the study group were men with mean disease duration of 12 years compared to an average duration of 8 years in the control group — a significant difference (<i>P</i> = 0.05). This finding confirms that risk of DFU increases with disease duration and underscores the importance of implementing prophylactic measures as soon as possible following diagnosis of the disease, especially in the male population that usually takes less care of their health compared with women.<sup>3,17</sup></p>
<p> Health-related quality of life. The World Health Organization (WHO) has defined QoL as “the individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns.” This definition includes six domains: physical health, psychological state, levels of independence, social relationships, environmental features, and spiritual concerns.<sup>28-33</sup></p>
<p> The SF-36 questionnaire used in this study is a generic instrument derived from a questionnaire for health evaluation (Medical Outcomes Study, MOS)7,34,35 and is the most commonly used generic instrument for measuring HRQoL around the world.<sup>36,37</sup></p>
<p> According to D’Amorim,<sup>30</sup> low patient educational level reduces the quality of information obtained with self-administered questionnaires. In the present study, 8.6% of the patients were illiterate and 65.7% had only elementary education. Patients with low sociocultural level and only elementary education are better assessed through interviews. The interview approach also increases study participation rates<sup>38</sup>; in the current study, 100% of participants completed the interview. </p>
<p> SF-36 scores were significantly lower in the study group than in the control group in the following domains: physical functioning (<i>P</i> = 0.043), role physical (<i>P</i> = 0.003), social functioning (<i>P</i> = 0.022), and role emotional (<i>P</i> = 0.001). Mean scores on all SF-36 domains were lower in the study group than in the control group.</p>
<p> Several studies have investigated the QoL of patients with foot ulcers.<sup>6,15-20,39-43</sup> Current study results are similar to the findings of other studies using the RAND 36-Item Health Survey (RAND-36) and Walking Stairs Questionnaire (WSQ) that reported low QoL in patients with DFUs, especially concerning mobility and physical and social functioning.<sup>6,15,16</sup> Tennvall and Apelqvist<sup>31</sup> reported that the extensive impact of mobility limitations led to a cascade effect in every QoL domain. </p>
<p> Goodridge et al<sup>41</sup> compared QoL parameters in 104 patients with healed and unhealed DFUs (defined as having a history of diabetic foot ulcers ≥6 months) who received care in a tertiary foot care clinic. Results using the Short Form 12 questionnaire showed that the unhealed DFU group had a greater reduction than the healed DFU group in overall physical health compared to patients with DM and no history of an ulcer, patients with hypertension, and persons in the general population. Additionally, significantly reduced QoL scores were found in the unhealed DFU group compared with the healed DFU group in several measures of physical health (<i>P</i> P 41 </p>
<p> In another cross-sectional study, Ribu et al<sup>42</sup> evaluated the HRQoL in patients with DFUs (n = 127) by comparing their HRQoL with that of a sample from the general population without diabetes (n = 5,903) and a subgroup with diabetes and no DFU (n = 221) to examine differences between groups by sociodemographic characteristics and lifestyle factors. Data on sociodemographic characteristics, lifestyle, and HRQoL (SF-36) were obtained. In all the SF-36 domains and in the two SF-36 summary scales, patients with DFUs reported significantly lower HRQoL than the DM population without DFU. The most striking differences observed were in the role physical (32.1 versus 62.2, <i>P</i> P P P P P 42</p>
<p> In a multicenter prospective study, Nabuurs-Franssen et al<sup>43</sup> evaluated HRQoL in 294 patients (ulcer duration ≥4 weeks) and 153 caregivers at three time points: baseline (T0), when the ulcer was healed or after 20 weeks (T1), and 3 months later (T2). The mean age of the patients was 60 years, 72% were male, and time since diagnosis of diabetes was 17 years. Patients reported a low HRQoL on all SF-36 domains. At T1, HRQoL scores in physical and social functioning were higher for patients with a healed versus a nonhealed ulcer (<i>P</i> P P 43 Price<sup>16</sup> and Wild<sup>36</sup> also reported a significant reduction in the QoL in patients with DFUs especially in role physical, social functioning, and mobility. The current study results suggest that DFUs reduce HRQoL, regardless of patient nationality. </p>
<p> <b>Self-esteem.</b> Generic instruments such as the SF-36 have the advantage of allowing QoL comparisons between patients with different diseases and between different socio-demographic groups. However, they do not allow evaluation of specific aspects of health, such as self-esteem. Therefore, it was important to complement the results from the SF-36 with the use of a specific instrument, such as the Rosenberg self-esteem scale (UNIFESP-EPM),<sup>7,13,14</sup> to evaluate an important aspect of the human life — ie, self-esteem.<sup>13,14</sup> In this study, the mean self-esteem score was higher in persons with a DFU than in the control group but the difference was not statistically significant. </p>
<h3>Limitations and Implications </h3>
<p> Limitations of the current study include the small sample size of both the study and control group. Additional studies in different regions of Brazil and using larger and more homogeneous samples are needed. In addition, future studies could include assessments of specific quality of life aspects, such as depression, life satisfaction, and self-image.</p>
<p> A longer life expectancy has led to an increasing number of older adults with chronic diseases such as DM that may limit physical functioning above-and-beyond general limitations observed with increasing age. As a result, there is an increasing the need to develop strategies for improving QoL in persons with and without wounds by implementing wound care programs, as well as programs to enhance muscle strength and joint flexibility and to improve social integration of the elderly inside and outside the family.<sup>20</sup></p>
<p>Conclusion
</p><p> The results of this cross-sectional comparative study confirm that patients with DFUs have lower HRQoL scores than patients with DM without ulcers. HRQoL scores were lower in all SF-36 domains, and significantly lower in the physical functioning, role physical, social functioning, and role emotional domains. Rosenberg self-esteem scores were similar for both groups. </p>
<p> These studies may stimulate the establishment of wound prevention programs for patients with DM and improve treatment of patients with DFUs by including psychological support to help reduce emotional distress. </p>
<p><i>Dr. Meneses is a Full Professor, Department of Anatomy, Sapucai Valley University — UNIVAS, MG, Brazil. Dr. Blanes is an instructor and Coordinator of the Wound Care Team; Dr. Veiga and Dr. Gomes are Associate Professors; and Dr. Ferreira is a Full Professor and Chairwoman and Head, Division of Plastic Surgery, Federal University of Sao Paulo—UNIFESP, SP, Brazil. Please address correspondence to: Leila Blanes, RN, PhD, Division of Plastic Surgery—UNIFESP, Rua Napoleao de Barros 715, 4˚, andar, Vila Clementino, 04023-062, Sao Paulo, SP, Brazil; email: <a href="mailto:luizmeneses@yahoo.com.br">luizmeneses@yahoo.com.br</a>.</i></p>
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<p>8. Brazier DJ, Harper R, Jones NMB, et al. Validating the SF-36 health survey questionnaire: new outcome measure for primary care. <i>BMJ</i>. 1992;305:160–164.</p>
<p>9. Blanes L, Carmagnani MIS, Ferreira LM. Health-related quality of life of primary caregivers of persons with paraplegia. <i>Spinal Cord</i>. 2007;45:399–403.</p>
<p>10. Ciconelli RM, Ferraz MB, Santos W, Meinão I, Quaresma MR. Tradução para a língua portuguesa e validação do questionário genérico de avaliação de qualidade de vida SF-36 (Brasil SF-36). <i>Rev Bras Reumatol</i>. 1999;39:143–150.</p>
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<p>13. Dini GM, Quaresma MR, Ferreira LM. Adaptação cultural e validação da versão brasileira da escala da auto-estima de Rosenberg. <i>Rev Soc Bras Cir Plast</i>. 2004;19(1):41–52.</p>
<p>14. Rosenberg M. <i>Society and the Adolescent Self Image</i>. Princeton, NJ: Princeton University Press;1965:326.</p>
<p>15. Silva E, Ribeiro JP, Cardoso H, Ramos H. Qualidade de vida e complicações crônicas da diabete. <i>Anál Psicol</i>. 2003;2:185–194.</p>
<p>16. Price P. The diabetic foot: quality of life. Clin Infect Dis. 2004;39(2):5129–5131.<br />
17. Calsolari MR, Castro RF, Maia RM, et al. Análise retrospectiva dos pés de pacientes diabéticos do ambulatório de diabetes da Santa Casa de Belo Horizonte, MG. <i>Arq Bras Endocrinol Metab</i>. 2002;46(2):173–176.</p>
<p>18. Armstrong DG, Lavery LA. Diabetic foot ulcers: prevention, diagnosis and classification. <i>Am Fam Phys</i>. 1998;57(6):1325–1339.</p>
<p>19. Haddad MC, Almeida HG, Gyariente MHDM, Karino ME, Barcellos MR. Avaliação sistematica do pé diabético. <i>Diabetes Clínica</i>. 2005;3:199–204.</p>
<p>20. Minayo MCS, Hartz ZMA, Buss PM. Qualidade de vida e saúde: um debate necessário. <i>Ciências &amp; Saúde Coletiva</i>. 2000;5(1):7–18.</p>
<p>21. Segre M, Ferraz FC. O conceito de saúde. <i> Rev Saúde Pública</i>. 1997;31(5):538–542.</p>
<p>22. The WHOQOL Group. The World Health Organization Quality of Life Assessment (WHOQOL): position paper from the World Health Organization. <i>Soc Sci Med</i>. 1995;41:1403–1409.</p>
<p>23. Barros N. Dor e qualidade de vida em pacientes com câncer. <i>Rev Dor</i>. 2000;2:24–29. </p>
<p>24. Langenhoff BS, Krabbe PFM, Wobbes T, Ruers TJM. Quality of life as an outcome measure in surgical oncology. <i>Br J Surg</i>. 2001;88(5):643–652.</p>
<p>25. Costa Neto SB. <i>Qualidade de vida nos portadores de câncer da cabeça e pescoço [Thesis]</i>. Brasília-DF: Universidade de Brasília;2002.</p>
<p>26. McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): psychometric and clinical tests of validity in measuring physical and mental health constructs. <i>Med Care</i>. 1993;31(3):247–263.</p>
<p>27. Tarlov AR, Ware JE Jr, Greenfield S, Nelson EC, Perrin EP, Zubkoff M. The Medical Outcomes Study: an application of methods for monitoring the results of medical care. <i>JAMA</i>. 1989;262(7):925–930.</p>
<p>28. Fitzpatrick R, Jenkinson C, Klassen A, Goodacre T. Methods of assessing health-related quality of life and outcome for plastic surgery. <i>Br J Plast Surg</i>. 1999;52(4):251–255.</p>
<p>29. Ganz PA, Day R, Ware JE Jr, Redmond C, Fisher B. Base-line quality of life assessment in the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial. <i>J Natl Cancer Inst</i>. 1995;87(18):1372–1382. </p>
<p>30. D’Amorim AB. Avaliação das formas auto-administradas dos questionários MHAQ E SF-12 em pacientes com doenças reumáticas [Thesis]. São Paulo: Universidade Federal de São Paulo-Escola Paulista de Medicina;2001.</p>
<p>31. Tennvall GR, Apelqvist J. Health-related quality of life in patients with diabetes mellitus and foot ulcers. <i>J Diabetes Complications</i>. 2000;14(59):235–241.</p>
<p>32. Evans AR, Pinzur MS. Health-related quality of life of patients with diabetes and foot ulcers. <i>Foot Ankle Int</i>. 2005;26(1):32–37.</p>
<p>33. Reiber GE, Lipsky BA, Gibbons GW. The burden of diabetic foot ulcers. <i>Am J Surg. 1998;176 (2A suppl):5S–10S.</i></p>
<p>34. Vileikyte L. Diabetic foot ulcers: a quality of life issue. <i>Diabetes Metab Res Rev</i>. 2001;17(4):246–249.</p>
<p>35. Salomé GM, Blanes L, Ferreira LM. Capacidade funcional dos pacientes com diabetes mellitus e pé ulcerado. <i>Acta Paul Enferm</i>. 2009;22(4):412–416. </p>
<p>36. Wild S, Roglic G, Green A, Sicree R, King H Global presence of diabetes estimates for the year 2000 and projections for 2030. <i>Diabetes Care</i>. 2004;27(5):1047–1053. </p>
<p>37. Brasil Ministério da Saúde. Departamento de Atenção Básica. Área técnica de Diabetes e Hipertensão Arteirial. Hipertensão Arteirial Sistêmica e Diabetes mellitus: protocolo. Brasília: Ministério da saúde. 2001. </p>
<p>38. Torquato MT, Montenegro M Jr, Viana LA, et al. Prevalence of diabetes mellitus and impaired glucose tolerance in the urban population aged 30–69 years in Ribierão Preto. <i>São Paulo Med J</i>. 2003;121(6):224–230. </p>
<p>39. Lopes CF. Projeto de assistência ao pé do paciente portador de diabetes melito. <i>J Vasc Br</i>. 2003;2(1):79–82.</p>
<p>40. Snyder RJ, Hanft JR. Diabetic foot ulcers — effects on QOL, costs, and mortality and the role of standard wound care and advanced-care therapies. <i>Ostomy Wound Manage</i>. 2009;55(11):28¬38.</p>
<p>41. Goodridge D, Trepman E, Sloan J, et al. Quality of life of adults with unhealed and healed diabetic foot ulcers. <i>Foot Ankle Int</i>. 2006;27(4):274–280. </p>
<p>42. Ribu L, Hanestad BR, Moum T, Birkeland K, Rustoen T. A comparison of the health-related quality of life in patients with diabetic foot ulcers, with a diabetes group and a nondiabetes group from the general population. <i>Qual Life Res</i>. 2007;16(2):179–189.</p>
<p>43. Nabuurs-Franssen MH, Huijberts MSP, Nieuwenhuijzen Kruseman AC, Willems J, Schaper NC. Health-related quality of life of diabetic foot ulcer patients and their caregivers. <i>Diabetologia</i>. 2005;48(9):1906–1910.</p>
</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-7">Feature</a></div></div></div>Fri, 04 Mar 2011 05:00:00 +0000hmpadmin1627 at http://www.o-wm.comhttp://www.o-wm.com/content/health-related-quality-life-and-self-esteem-patients-diabetic-foot-ulcers-results-cross-sect#commentsSpray on skin developed for burn victimshttp://www.o-wm.com/content/spray-skin-developed-burn-victims
<div class="field field-name-field-news-link field-type-link-field field-label-above"><div class="field-label">Link:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="http://www.o-wm.com/content/spray-skin-developed-burn-victims" target="_blank" rel="nofollow">[title]</a></div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><p><a href="#" onclick="return(false);" rel="videoGUID=99bea3ec-355a-11e0-8c71-12313804d1b3&amp;" style="display:block;width:512px;height:308px" id="99bea3ec-355a-11e0-8c71-12313804d1b3" width="512" height="308">2011_02_10 15_56_15_328.mp4</a> </p>
<script type="text/javascript" src="http://360.sorensonmedia.com/99bea3ec-355a-11e0-8c71-12313804d1b3/embedv2.js"></script><p> Doctors have invented a revolutionary skin spray-gun that heals severe burns within days. The spray-gun, which fires stem cells on to the damaged skin has already been used successfully on a dozen patients and the process only takes 90 minutes. The following video clip offers an inside look at the revolutionary gun that was recently featured on the National Geographic Channel.</p>
<p> For more information, visit <a href="http://www.telegraph.co.uk/health/healthnews/8302720/Spray-on-skin-developed-for-burns-victims.html">http://www.telegraph.co.uk/health/healthnews/8302720/Spray-on-skin-devel...</a>. </p>
</div></div></div>Thu, 10 Feb 2011 21:25:17 +0000hmpadmin1606 at http://www.o-wm.comhttp://www.o-wm.com/content/spray-skin-developed-burn-victims#commentsVolume 57 - Issue 2 - February 2011http://www.o-wm.com/content/volume-57-issue-2-february-2011-0
<div class="field field-name-field-issue-date field-type-text field-label-above"><div class="field-label">Journal Date:&nbsp;</div><div class="field-items"><div class="field-item even">February 2011</div></div></div><div class="field field-name-field-volume-number field-type-number-integer field-label-above"><div class="field-label">Volume Number:&nbsp;</div><div class="field-items"><div class="field-item even">57</div></div></div><div class="field field-name-field-issue-number field-type-text field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even">2</div></div></div><div class="field field-name-field-publication-date field-type-date field-label-above"><div class="field-label">Publish Date:&nbsp;</div><div class="field-items"><div class="field-item even"><span class="date-display-single">Tuesday, February 8, 2011</span></div></div></div>Tue, 08 Feb 2011 18:07:47 +0000hmpadmin1592 at http://www.o-wm.comNutrition 411: Selecting the Right Tube-Feeding Formulahttp://www.o-wm.com/content/selecting-right-tube-feeding-formula
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/1592">Volume 57 - Issue 2 - February 2011</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Nancy Collins, PhD, RD, LD/N, FAPWCA</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><p> Because of the many different tube-feeding products on the market today, formula selection can be quite confusing. The task becomes more complicated if the patient has several comorbidities. Imagine trying to select just the right formula for a patient with diabetes, renal insufficiency, and a pressure ulcer who is overweight but has very little muscle mass and states he has a history of constipation. In order to have the best possible patient outcome, it is important to select the most appropriate formula, particularly if the patient is NPO and fully dependent on tube feeding to meet 100% of his nutritional needs. Clinicians should understand the basic product characteristics available before contemplating specific choices. </p>
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<h3>Caloric Density</h3>
<p> A standard or so-called “house” tube-feeding formula usually provides 1 calorie per 1 milliliter (mL) and a nutrient composition quite similar to what is recommended for healthy individuals. There are also formulas that provide anywhere from 1.2 to 2.0 calories per mL. Caloric density is an important consideration for patients with volume restrictions. For example, 1 L of a standard product provides 1,000 calories. If a patient is volume-restricted due to congestive heart failure, pulmonary insufficiency, impaired renal function, or other problem, the same 1 L of a more calorically dense product can provide 1,500 or even 2,000 calories. Calorically dense formulas often are used for overnight feedings or bolus feedings where the aim is to give the patient a large number of calories in a short amount of time. However, there are some trade-offs, such as an increase in osmolality.</p>
<h3>Osmolality</h3>
<p> Osmolality is the measure of size and quantity of ionic and molecular particles within a given volume. The unit of measure is mOsm/kg of water. Isotonic means that a formula is within the normal physiologic range, approximately 300 mOsm/kg of water.<sup>1</sup> Generally, tolerance problems are minimized by using an isotonic formula. As more calories are packed into a given volume, more molecular particles are present; hence, the osmolality rises. These formulas are hypertonic and can be as high as 1,000 mOsm/kg of water or more. Patients will tolerate products differently depending on their specific medical condition and gut integrity, but a higher osmolality can mean a greater risk of tolerance problems such as osmotically induced diarrhea. Formulas can be diluted with water to decrease the osmolality but this is discouraged because today, patients are frequently fed using a closed delivery system. A more common approach to dealing with high osmolality formulas is to begin at a lower infusion rate and advance gradually toward the goal rate while monitoring gastrointestinal tolerance.</p>
<h3>Delivery Systems</h3>
<p> Depending on how a tube-feeding product is packaged, infusion is via an open or closed delivery system. The open system utilizes either a large syringe or an open-top container for tube-feeding delivery. Products include flip-top cans, bottles, brick packs, or powder packages that require reconstitution with water. In the closed system, a container is prefilled with the sterilized tube-feeding product; the bottle then is spiked with tubing and attached to the enteral access device. The container usually contains at least 1 L of product and formula hang time is usually between 24 and 36 hours, as long as sterile technique is used.</p>
<h3>Fiber Content</h3>
<p> Tube-feeding products vary in the amount and type of fiber they contain. If a patient is suffering from diarrhea or constipation, it is important to look at the fiber content of the formula. Sources of fiber in enteral formulas include both soluble and insoluble fiber. Insoluble fiber, also known as bulking fiber, does not dissolve in water. Soluble fiber dissolves in water and helps moderate bowel function. A balance between both types often is used; this minimizes concerns about the fiber clogging a feeding tube because of the increased viscosity from the soluble fiber. In addition, some formulas contain fructooligosaccharides (FOS). FOS are a type of prebiotic, a substance that helps maintain an optimal ecological balance in the gastrointestinal tract. FOS also may help control Clostridium difficile infections by restoring the gut microflora and creating an environment that inhibits growth of the pathogen.<sup>2</sup></p>
<h3>Formula Composition</h3>
<p> Another way to classify tube-feeding products is by the degree of digestion necessary before absorption. Before selecting a formula, the patient’s digestive and absorptive capacity must be assessed. A formula with the appropriate-sized molecules then can be ordered. There are three broad classes of products: polymeric, peptide-based, and modular. Polymeric formulas contain intact protein. Patients who have normally functioning digestive tracts should be able to digest and tolerate intact proteins. However, persons with impaired GI function may have difficulties with polymeric formulations. Peptide-based formulas may be better tolerated in these cases because the protein source is hydrolized protein, di- or tri-peptides, or free amino acids. Modular formulas supply only one macronutrient, usually protein or fat. Modules often are used to customize or adjust another formula. For example, in order to increase the protein content of a standard formula, a protein module can be added in the form of protein powder or liquid. Like adding water to a dilute a tube feeding, the practice of adding modular products to a closed system is discouraged because of infection control risks. The act of opening a closed delivery system defeats the original intent of the closed system. In addition, with the number of formulas available today, it is often simply a matter of selecting a different formula because one is available for almost every need.</p>
<h3>Vitamins/Minerals/Electrolytes</h3>
<p> Each formula requires a different volume to meet 100% of the recommended dietary intake (RDI) of vitamins and minerals. The manufacturer’s information typically lists the number of calories and number of mL required to reach 100%. For example, a patient on Perative (Abbott Nutrition, Columbus, OH) would have to receive 1,155 mL or 1,500 calories to meet 100% of the RDIs.<sup>3</sup> This issue is important when considering patients with certain diseases such as renal or hepatic insufficiency. Formulas specifically made for these diagnoses tend to have a lower amount of vitamins, minerals, and electrolytes. It is important to read the label if you are concerned about the amount of a certain vitamin or mineral.</p>
<h3>Disease-specific Formulas</h3>
<p> Formulas are available to treat specific conditions such as pulmonary disease, impaired glucose tolerance, renal disease, immunocompetence disorders, and others. Although some practitioners may think disease-specific formulas have more to do with marketing than science, many of these products contain proprietary ingredients or nutrient compositions that make them markedly different from a standard or house formula. Several studies have been conducted comparing a disease-specific formula to a standard formula. In a 2009 study,<sup>4</sup> two different protocols were used to measure postprandial glycemia and insulinemia. The first protocol was used in 22 subjects with diabetes who were fed a diabetes-specific or standard formula. In the second protocol, continuous glucose monitoring was used to assess glucose levels in 12 enterally fed patients with diabetes receiving the standard formula followed by the diabetes-specific formula continuously for 5 days each. End points included postprandial glycemia and insulinemia, glycemic variability (mean amplitude of glycemic excursions [MAGE]), mean glucose, and insulin use. The diabetes-specific formula reduced postprandial glycemia, mean glucose, glycemic variability, and short-acting insulin requirements. According to the authors, these results suggest potential clinical usefulness of a diabetes-specific enteral formula for minimizing glycemic problems in hospitalized patients. This reiterated the conclusion found in an earlier meta-analysis<sup>5</sup> of 23 studies (comprising 784 patients) of oral supplements (16 studies) and tube feeding (seven studies). The majority of the studies compared diabetes-specific with standard formulas. The aim of this systematic review was to determine the benefits of nutritional support in patients with type 1 or type 2 diabetes. These authors concluded that short- and long-term use of diabetes-specific formulas as oral supplements and tube feedings were associated with improved glycemic control compared with standard formulas. They state that if such nutritional support is given long term, this may have implications for reducing chronic complications of diabetes, such as cardiovascular events. That said, in clinical practice some institutions support the use of disease-specific formulas while others do not. It is up to each practitioner to become familiar with the various products and the relevant literature in order to make an informed judgment that will produce the best outcome possible for each individual patient.</p>
<h3>Practice Points</h3>
<p> Table 1 highlights some of the products currently available, including those most commonly used for patients with wounds. Most facilities follow a formulary, but the formulary should be reviewed annually and new products tried as they become available. Product representatives are always happy to supply samples for a trial period, so investigate some of the products you may not currently use. Employ critical thinking skills to evaluate the merits of each formula by reading the label, understanding the ingredients, and reading the research. Registered dietitians (RDs) are your resource for tube-feeding information — order a consultation when necessary. Selecting the formula is only the first step. Infusion rates, tolerance problems, hydration issues, body weight changes, and many other physiological and ethical issues also may need attention. <a href="/files/owm/feb_nutrition411_table1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/imagecache/thumbnails/feb_nutrition411_table1.jpg" style="float:right" /></a></p>
<h3>Coming next month: Dysphagia</h3>
<p><em>Nancy Collins, PhD, RD, LD/N, FAPWCA, is founder and executive director of RD411.com and Wounds411.com. For the past 20 years, she has served as a consultant to healthcare institutions and as a medico-legal expert to law firms involved in healthcare litigation. Correspondence may be sent to Dr. Collins at <a href="mailto:NCtheRD@aol.com">NCtheRD@aol.com</a>. This article was not subject to the Ostomy Wound Management peer-review process.</em></p>
</div></div></div><div class="field field-name-field-references-field field-type-text-long field-label-above"><div class="field-label">References:&nbsp;</div><div class="field-items"><div class="field-item even"><p>1. Mahan LK, Escott-Stump S. <em>Krause’s Food, Nutrition &amp; Diet Therapy, 10th ed</em>. Philadelphia, PA: WB Saunders Company;2000:156.</p>
<p>2. Dorner B. Nutrition Therapy for C. difficile Diarrhea. <em>Assisted Living Consult</em>. 2007;12-13,18. Available at: <a href="http://www.assistedlivingconsult.com/issues/03-05/alc910-Nutrition-919.pdf">www.assistedlivingconsult.com/issues/03-05/alc910-Nutrition-919.pdf</a>. Accessed January 18, 2011.</p>
<p>3. Abbott Nutrition. Available at <a href="http://abbottnutrition.com/Products/perative">http://abbottnutrition.com/Products/perative</a>. Accessed January 18, 2011.</p>
<p>4. Alish CJ, Garvey WT, Maki KC, et al. A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes. <em>Diabet Technol Ther</em>. 2010;12(6):419–425.</p>
<p>5. Elia M, Ceriello A, Laube H, Sinclair AJ, Engfer M, Stratton RJ. Enteral nutritional support and use of diabetes-specific formulas for patients with diabetes. <em>Diabetes Care</em>. 2005;28:2267–2279. Available at: <a href="http://care.diabetesjournals.org/cgi/content/full/28/9/2267">http://care.diabetesjournals.org/cgi/content/full/28/9/2267</a>. Accessed January 18, 2011.</p>
</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-69">Featured Department</a></div><div class="field-item odd"><a href="/topics/section-33">Nutrition 411</a></div></div></div>Tue, 08 Feb 2011 05:00:00 +0000hmpadmin1597 at http://www.o-wm.comhttp://www.o-wm.com/content/selecting-right-tube-feeding-formula#commentsIschemia-Reperfusion Injury-Induced Histological Changes Affecting Early Stage Pressure Ulcer Development in a Rat Model http://www.o-wm.com/content/ischemia-reperfusion-injury-induced-histological-changes-affecting-early-stage-pressure-ulce
<div class="field field-name-field-issue-num field-type-node-reference field-label-above"><div class="field-label">Issue Number:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/issue/1592">Volume 57 - Issue 2 - February 2011</a></div></div></div><div class="field field-name-field-pdfversion field-type-file field-label-hidden"><div class="field-items"><div class="field-item even"><span class="file"><img class="file-icon" alt="" title="application/pdf" src="/sites/all/themes/owm_7/img/icons/application-pdf.png" /> <div style="display: inline-block;width: 120px;vertical-align: middle;text-align: center;"><a href="/user/login">Login to</a>Download PDF version</div></span></div></div></div><div class="field field-name-field-index field-type-text field-label-inline clearfix"><div class="field-label">Index:&nbsp;</div><div class="field-items"><div class="field-item even">Ostomy Wound Manage. 2011;57(2).</div></div></div><div class="field field-name-field-author field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even">Li-ping Jiang, PhD, RN; Qian Tu, RN; Yanyan Wang, RN; and En Zhang, RN</div></div></div><div class="field field-name-taxonomy-vocabulary-3 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Topics:&nbsp;</div><div class="field-items"><div class="field-item even">Pressure Ulcer</div><div class="field-item odd">ischemia-reperfusion</div><div class="field-item even">injury</div></div></div><div class="field field-name-body field-type-text-with-summary field-label-hidden"><div class="field-items"><div class="field-item even"><p> <strong>Abstract</strong><br />
Pressure ulcers (PU) are caused by the interplay of multiple factors including skin microcirculation. Ischemia-reperfusion (I/R) injury is considered a significant mechanism in the early stages of pressure ulcer development. The objective of this controlled, single-blinded in vivo study was to create a pressure-induced injury rat animal model and explore the possible mechanism and effects of I/R injury in early stage PU development using clinically relevant amounts of pressure and pressure duration.</p>
<!--break--><p>Forty-eight animals were randomly divided into six groups of eight and a 2.5 cm x 2.5 cm area of the hip was subjected to no pressure (control), ischemia only (IG – 2 hours of 70 mm Hg pressure), or one of four I/R cycles (70 mm HG of pressure for 2 hours followed by 1, 2, 3, or 4 hours of reperfusion). All I/R cycles were repeated three times. Full-thickness skin samples from the compressed area were harvested for histopathology and femoral artery blood samples obtained to measure serum levels of the following inflammatory mediators: malondialdehyde (MDA), superoxide dismutase (SOD) nitric oxide (NO) and endothelin-1 (ET-1). MDA, NO, and ET-1 levels were significantly higher in the IR than the control (<em>P</em> &lt;0.01) and ischemia groups (<em>P</em> &lt;0.05); whereas, SOD activity was significantly lower than in the IG and control groups (<em>P</em> &lt;0.05). {C}</p>
<p> The largest differences were observed in the 2-hour ischemia/3-hour reperfusion group. Biopsy analysis by lightmicroscopy stain showed no changes in the control, mild changes in the IG, and considerable damage, including leukocyte infiltration, collagen fibrosis, and edema in epidermal, dermal, and muscle tissue from the I/R group. These findings suggest that hypoxic-ischemic tissue injury occurs early following a period of ischemia and that I/R may be an important mechanism in PU development. Although the mechanisms of I/R injury are probably multifactorial and the actions of free radicals may be more complicated in the early stages of PU development in humans, the findings suggest that a minimum of 4 hours pressure relief may be helpful for PU prevention. Research to elucidate these mechanisms and their potential interactive effects to help clinicians develop evidence-based prevention protocols are warranted.</p>
<p><strong>Potential Conflicts of Interest:</strong> none disclosed</p>
<p><a href="/files/owm/jiang_keypoints.jpg" rel="lightbox" title="Key Points"><img src="/files/owm/imagecache/thumbnails/jiang_keypoints.jpg" style="float:right" /></a> A pressure ulcer (PU) is a localized injury to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure in combination with shear and/or friction. PU development prolongs hospitalization, increases disability, interferes with patient rehabilitation, and may contribute to patient death.<sup>1</sup> Despite extensive work directed toward PU prevention and treatment, clinical outcomes have not appreciably changed over the past decades.<sup>2</sup> This may be related to the fact that the pathophysiology of PU formation is still incompletely understood.</p>
<p> Early PU studies suggested that impaired or disrupted tissue integrity is the result of prolonged pressure.<sup>3</sup> PU severity ranges from erythema of intact skin to tissue destruction involving skin, subcutaneous fat, muscle, and bone.<sup>4</sup> The tissue injury can lead to loss of the stratum corneum, development of hyperemic thrombi in capillaries and venules, and ultimately necrosis and ulceration of the dermis and epidermis. Most animal models of chronic PU were designed to study the role of ischemic injury in wound formation by, for example, applying cutaneous pressure. In early studies,<sup>5,6</sup> histopathologic changes were found to occur in tissues subjected to as little as 60 mm Hg for 1 hour because at pressures &gt;35 mm Hg, capillaries will close and ischemic injury occurs. Kosiak<sup>5</sup> deduced an inverse relationship between pressure amount and duration<span style="line-height:1.6">.</span></p>
<p><span style="line-height:1.6"> Daniel et al</span><sup>6</sup><span style="line-height:1.6"> linked PU development with pressure-induced ischemia through the use of a continuously monitored, computer-controlled, electromechanical pressure applicator. These results indicated that muscle injury occurs first and that muscle tissue is more susceptible to pressure than skin tissue. However, these models employed one-time constant pressure applications that may not accurately reflect how tissue pressure occurs in the clinical setting.</span><sup>7</sup></p>
<p> Shayn<sup>7</sup> developed an animal model to study the role of ischemia-reperfusion (I/R) in the PU development using small, unanesthetized animals whose skin was periodically compressed using 50 mm Hg. Jiang<sup>8</sup> hypothesized that the cyclic application and removal of pressure can cause I/R injury in the skin if the pressure is great enough to substantially reduce blood flow throughout its application period.</p>
<p> As result of these early studies, I/R injury now is considered a significant factor in the etiology of PU.<sup>9</sup> After I/R has occurred, an inflammatory response is incited and a mass of inflammatory mediators is released in the ischemic tissue which, in turn, results in the overproduction of cytotoxic oxygen-derived free radicals produced from myocytes such as malondialdehyde (MDA), superoxide dismutase (SOD), endothelin-1 (ET-1), and nitric oxide (NO) changes in blood plasma.<sup>10</sup> With an I/R injury, tissue and serum MDA levels increase and SOD enzymatic activity decreases. SOD activity is thought to prevent free-radical formation and lessen or inhibit the damage caused by postischemic reperfusion.<sup>11</sup> ET-1 regulates the release of vasoactive substances and stimulates smooth muscle mitogenesis.<sup>12</sup> NO mediates a variety of biological functions, including endothelium-dependent vasodilatation, oxygen radical scavenging, inhibition of platelet aggregation, and reduction of leukocyte-endothelial cell adhesion in the early stage of reperfusion.<sup>12,13</sup> Administration of exogenous ET-1 and/or NO may help maintain physiological vascular tone, subsequently protecting the endothelium from oxygen-free I/R injury primarily caused by oxygen radicals.</p>
<p> Changes in these mediators can produce further tissue damage. Histological evidence indicates excessive free radicals will mediate tissue injury and ET-1 and NO changes will affect bioactivity on the vascular walls.<sup>14</sup></p>
<p> Free radicals can generate the lipid peroxidation process. After I/R injury in a rat model,<sup>15</sup> subsequent bleeding was thought to be related to overproduction of reactive oxygen species (ROS), which is involved directly in lipid peroxidation, especially for hydroxyl radicals. I/R injury induces vasospasm through blood vessel contraction or NO depletion. In animal models,<sup>16</sup> levels of MDA and SOD are common markers of oxidative stress and antioxidant status.</p>
<p> Based on a variety of pressure models, it is clear that localized pressure results in the accumulation of metabolic byproducts and cell necrosis. With intermittent pressure, I/R injury will lead to hypoxic-ischemic tissue damage.<sup>17</sup> The objective of this controlled, single-blinded in vivo study was to create a pressure-induced injury animal model and explore the possible mechanism and affects of I/R injury in early stage pressure ulcer development using clinically relevant amounts of pressure and pressure duration.</p>
<h3>Materials and Methods</h3>
<p> <strong>Animal model.</strong> This study was approved by the Institutional Animal Care and Use Committee (IACUC) of Wenzhou Medical College (WMC) and was carried out in compliance with institutional guidelines for care and use of animal models. A total of 48 Wister rats (24 male, 24 female, body weight 220 g ± 20 g) were obtained from the Laboratory Animal Center of Wenzhou Medical College. Each animal was housed under standard laboratory conditions (12 hours light, 12 hours dark cycles, temperature 2˚ C ± 12˚ C, humidity 60% ± 5%) and maintained on standard laboratory food and water.</p>
<p> An animal model for early stage pressure ulcer development was set up using clinically relevant pressures and durations. Specifically, a protocol of a 2-hour period of ischemia, followed by 1 to 4 hours of reperfusion, is clinically relevant18 because it is recommended that patients at risk for developing pressure ulcers should be turned at least every 2 hours. This I/R protocol, using 70 mm Hg, previously has been shown in a rat animal model<sup>7,8</sup> to produce significant skin necrosis with ulcer formation. After completing three cycles of intermittent pressure, full-thickness skin from the compressed area was harvested for histopathologic and tissues examination.</p>
<p> <strong>Experimental groups.</strong> The 48 rats were randomly divided into six groups, eight rats per group, one thigh injury per animal. The control (no treatment) and ischemia-only (IG) groups sustained compression for 2 hours. The I/R groups were further divided into four subgroups according to the following reperfusion schedule: 1) 2 hours ischemia plus 1 hour reperfusion (I/R1hG), 2) 2 hours ischemia plus 2 hours reperfusion (I/R2hG); 3) 2 hours ischemia plus 3 hours reperfusion (I/R3hG), and 4) 2 hours ischemia plus 4 hours reperfusion (I/R4hG) (see Table 1).</p>
<p><a href="/files/owm/jiang_table1.jpg" rel="lightbox" title="Table 1"><img src="/files/owm/imagecache/thumbnails/jiang_table1.jpg" style="float:right" /></a> Animals were anesthetized with subcutaneous injections of 10% chloral hydrate (300 mg/Kg body weight). Anesthesia was maintained with isoflurane inhalation (0.4% to 1.0% isoflurane with N<sub>2</sub>O/O<sub>2</sub> mixture 1:1) during all procedures. Vital signs (pulse and respiratory rate) were monitored and maintained within the normal physiological range. The anesthetized rats were placed supine in the loading device.8,18 A pressure of 70 mm Hg was applied to a 2.5 cm × 2.5 cm region of upper leg/thigh skin using a 500-g metal plate.6 A maximum of three compression cycles was administered, followed by a period of 1 to 4 hours of reperfusion.</p>
<p> After three cycles of I/R or 2 hours of sustained compression in the non-I/R groups, full-thickness skin samples from the compressed area were harvested and histopathology analysis performed. Tissues were fixed in 10% buffered formalin, embedded in paraffin wax, and then sliced at thickness of 5 µm. The slices were stained with conventional hematoxylin and eosin (H&amp;E) in order to show the changes of microanatomy. At the same time, blood was collected from the femoral artery to measure serum the levels of MDA, NO, and ET-1 and SOD activity in plasma.</p>
<p> <strong>Biochemical analyses.</strong> Ten (10) mL plasma was put in tubes without anticoagulant and the serum collected. The blood serum was centrifuged at 3,600 rpm for 10 minutes at 4˚ C and the supernatant was frozen at -70° C. Colorimetric analysis was employed to measure NO, MDA, and SOD activity according to laboratory kit instructions (kits provided by Jiancheng Institute of Bioengineering, Nanjing).</p>
<p> The MDA content was determined spectrophotometrically by measuring the presence of thiobarbituric acid-reactive substances (free fatty acids with lipid peroxidation aldehydic products). Results are expressed as nmol/g.</p>
<p> SOD enzyme activity was determined by the production of H2O2 from xanthine by xanthine oxidase and reduction of nitroblue tetrazolium using spectrophotometry. Results are expressed as µ/g.</p>
<p> Tissue nitrite (NO<sub>2</sub>) and nitrate (NO) levels were used to estimate NO production. Quantification of NO<sub>2</sub> and NO<sub>3</sub> was based on the Griess reaction. Results are showed as µmol/g.</p>
<p> Measurements of ET-1 were performed with 30 µl 10% disodium ethylene diamine tetraacetate (EDTA•Na<sub>2</sub>) and 40 µl aprotinin. Radioimmunoassay was employed to assess amounts of ET-1. Results are expressed as pg/mL.</p>
<p> <strong>Histological assessment.</strong> Biopsied samples were immersed in buffered 10% formalin. Slides were prepared for light microscopy and stained with conventional H&amp;E. Histological changes of the epidermis, dermis, and muscle were evaluated by microscope (Olympus, Japan) and blinded to the animal’s group assignment. The pathological changes of tissue were assessed as ranging from no changes (normal) and mild changes to severe according to integrity of skin structure such as dermal infiltration of inflammatory cells and collagen and capillary and edema formation in the epidermis, dermis, and muscle.</p>
<p> <strong>Statistical analysis.</strong> Results of one-way analysis of variance (ANOVA) test for statistical significance analysis of variance for MDA, NO, SOD, and ET-1 levels are presented as mean ± standard deviation (SD). Comparisons were tested by Student-Newmann-Keuls test. A P value of &lt;0.05 was considered statistically significant. SPSS 11.0 (Chicago, IL) was used for data analysis.</p>
<h3>Results</h3>
<p> <strong>Biochemical assays.</strong> Average plasma SOD levels ranged from 225.88 ± 25.19 µ/L in the ischemia to 174.45 ± 46.61 in the I/R after 3 hours group (see Figure 1). The difference between the control and ischemia group and all four I/R groups was statistically significant (<em>P</em> &lt;0.05), with the largest difference observed between the I/R3hG and control group (<em>P</em> &lt;0.01).</p>
<p><a href="/files/owm/jiang_fig1.jpg" rel="lightbox" title="Figure 1"><img src="/files/owm/imagecache/thumbnails/jiang_fig1.jpg" style="float:right" /></a> Mean MDA levels were lowest in the control group (2.03 ± 0.93) and slightly higher in the ischemia group (2.97 ± 1.48). MDA levels in all I/R groups were significantly higher than the control (<em>P</em> &lt;0.01) and ischemia groups (<em>P</em> &lt;0.05) (see Figure 2). However, levels of SOD enzyme and MDA were not significantly different between the IG and control groups.</p>
<p><a href="/files/owm/jiang_figs234.jpg" rel="lightbox" title="Figures 2, 3, &amp; 4"><img src="/files/owm/imagecache/thumbnails/jiang_figs234.jpg" style="float:right" /></a> As with MDA levels, the lowest levels of ET-1 and NO were observed in the control (average 89.22 ± 2.62 and 95.45 ± 17.52, respectively) and the ischemia group (average 91.55 ± 1.23 and 92.04 ± 17.81, respectively) and the highest levels were observed in the 3-hour pressure-relief groups (100.94 ± 3.14 and 155.87 ± 10.67 (see Figures 3 and 4). ET-1 and NO levels were somewhat lower in the 4-hour pressure-relief groups but remained statistically significant compared to the control and ischemia groups (<em>P</em> &lt;0.01).</p>
<p> <strong>Histological assessment.</strong> Analysis of the biopsies by light-microscopy (H&amp;E) stain showed pressure-induced tissue changes. In the control group, no histological changes were observed (see Figure 5a,b). However, tissue biopsies from the ischemia group showed mild changes (see Figure 5c,d) and severe skin and muscle damage was observed in the group exposed to 2 hours of pressure followed by 1 to 4 hours of reperfusion (see Figure 5e,f). <a href="/files/owm/jiang_fig5.jpg" rel="lightbox" title="Figure 5"><img src="/files/owm/imagecache/thumbnails/jiang_fig5.jpg" style="float:right" /></a></p>
<h3>Discussion</h3>
<p> In this PU model, I/R injury and subsequent re-oxygenation of certain hypoxic myocytes was found to result in the release of free radicals. The mechanism underlying the observed higher levels of MDA and NO and lower levels of the SOD enzyme is most likely multifactorial and interdependent and involves hypoxia, inflammatory responses, and free-radical damage.<sup>19,20</sup> This finding is in accordance with results of flap-transfer studies in a rat model,<sup>21</sup> which showed tissue reperfusion injury, including the presence of free radicals and neutrophils. ET-1 levels were also higher after reperfusion (see Figure 3), a change that may be mediated by intravascular endothelial swelling and ET-1 mediated microvascular constriction.<sup>18 </sup></p>
<p> Interestingly, in this study, the difference in the average levels of biochemical predictors in the plasma of control tissue and tissue subjected to pressure/reperfusion increased with increasing reperfusion time and decreased slightly in the 4-hour reperfusion group. This suggests that most damage occurs during early reperfusion — ie, 1 to 3 hours following pressure relief — whereas, a prolonged period of pressure-relief (&gt;4 hours) may help tissues recover. Houwing et al<sup>22</sup> reported that after 4 hours of I/R, cytotoxic activity of free radicals decreased because deposits of glycogen and ATP were absent and cells could no longer restore them during reperfusion. This was different from previously described PU studies of short-term ischemia wound formation or simple reperfusion cycles.<sup>23,24</sup> The prolonged release time is advantageous to the degradation of MDA, SOD, and NO.</p>
<p> The current study results indicated that injury occurred in early-stage PUs in the epidermis, dermis, and muscle. One explanation may be that the pressure was applied on skin in the gluteus area, reducing capillary blood flow. Skeletal muscle may be more sensitive to ischemia than skin and exacerbate the potential for tissue necrosis.<sup>25</sup> Using a rat model, Peirce et al<sup>7</sup> reported that soft tissue could bear more pressure loads and for longer duration than muscle. Using laser Doppler flowmetry, Salcido et al<sup>10</sup> measured muscle blood perfusion and their findings suggest that muscle damage correlates with blood ischemia. Two reviews<sup>26,27</sup> propose that the activation and infiltration of polymorphonuclear cells and concomitant interaction with activated endothelial cells play a key role in reperfusion injury; the current study’s histological findings, showing infiltration of polymorphonuclear cells in the dermis and muscle, confirm these observations. It is hoped that results of this study will be help increase understanding of the mechanism behind the development of so-called deep-tissue injury PUs.<sup>23</sup></p>
<h3>Conclusion</h3>
<p> Using an animal model for pressure ulcer development and clinically relevant periods of pressure/ischemia (2 hours) and pressure-relief/reperfusion (1, 2, 3, and 4 hours), significant differences in the plasma level of inflammatory mediators were found. Levels of MDA, ET-1, and NO were significantly higher and SOD levels were significantly lower following I/R injury, especially after 1, 2, and 3 hours. These findings suggest that hypoxic-ischemic injury with I/R is an important mechanism in PU development and that epidermal, dermal, and muscle damage occurs within several hours. However, the mechanisms of I/R injury are probably multifactorial and the actions of free radicals may be more complicated in the early stages of PU development in humans as compared to the rat model. Seemingly, a minimum of 4 hours for the relief of local pressure might be helpful for PU prevention. Further research is needed to elucidate these mechanisms and potential interactive effects.</p>
<h3>Acknowledgment</h3>
<p> The research was supported from the Department of Science and Technology of Zhejiang province 2008C33044 and Wenzhou (Y20090007), China. The authors thank Professor Margaret Heitkemper, School of Nursing, University of Washington, for helping the authors write this paper in English.</p>
<p> <em>Dr. Jiang is a Professor and Dean; and Ms. Tu, Ms. Wang, and Ms. Zhang are Master of Science students, School of Nursing, Wenzhou Medical College, Zhejiang Province, China. Please address correspondence to: Professor Li-ping Jiang, Dean, School of Nursing, Wenzhou Medical College, Chashan University Town, Wenzhou, Zhejiang Province 325035, China; email: <a href="mailto:lgngjiang@yahoo.com">lgngjiang@yahoo.com</a>.</em></p>
<p> </p>
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</div></div></div><div class="field field-name-taxonomy-vocabulary-4 field-type-taxonomy-term-reference field-label-above"><div class="field-label">Section:&nbsp;</div><div class="field-items"><div class="field-item even"><a href="/topics/section-7">Feature</a></div></div></div>Tue, 08 Feb 2011 05:00:00 +0000hmpadmin1598 at http://www.o-wm.comhttp://www.o-wm.com/content/ischemia-reperfusion-injury-induced-histological-changes-affecting-early-stage-pressure-ulce#comments